Active, not recruitingNCT04166318Updated Sep 14, 2026

Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study

A Phase 2 interventional study of Biopsy and Biospecimen Collection in Anal Basaloid Carcinoma, Anal Canal Cloacogenic Carcinoma and Anal Canal Squamous Cell Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group. Active, not recruiting at 659 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by ECOG-ACRIN Cancer Research Group · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 252
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose chemoradiation therapy (CRT), as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year.

SECONDARY OBJECTIVES:

I. To compare changes in patient-reported HRQL (as per Fecal Incontinence Severity Index [FISI], Patient Reported Outcomes Measurement Information System [PROMIS], International Index of Erectile Function [IIEF], Sexual Function-Vaginal Changes Questionnaire [SVQ], and Vaginal Assessment Scale [VAS]/Vulvar Assessment Scale [VuAS] instruments) between the experimental and control arm.

II. To compare patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation), disease control, and overall survival between experimental and control arm.

III. To correlate vaginal dilator use during radiation delivery with sexual function.

IV. To measure changes in serum total testosterone from baseline to up to 12 months after radiation.

V. To validate the utility of imaging features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemoradiation is appropriate.

VI. To determine the incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil (5-FU) or capecitabine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (STANDARD-DOSE CHEMORADIATION): Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin intravenously (IV) over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine orally (PO) twice daily (BID) 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

ARM B (DE-INTENSIFIED CHEMORADIATION): Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.

All patients receive fludeoxyglucose F-18 (FDG) and undergo positron emission tomography (PET)/magnetic resonance imaging (MRI) or receive FDG and undergo PET/computed tomography (CT) during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for years 1-2, every 6 months for year 3, then annually for years 4-5.

Conditions studied

Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
Stage IIA Anal Cancer AJCC v8

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Anus Neoplasms 266

In context

Anus Neoplasms

266 studies on the registry are indexed under Anus Neoplasms; 71 are open to participants now.

This study's planned enrollment of 252 is above the median of 70 across 182 interventional studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

STEP 0 (PRE-REGISTRATION)
Patient must be ≥ 18 years of age
Patients must be English speaking to participate in the trial. (Please note that this requirement is due to the fact that the quality-of-life studies are mandatory and we currently do not have full translated versions of the questionnaires into other languages)
Patient must have histologically proven T1-2N0M0 invasive anal canal or anal margin squamous cell carcinoma with tumors measuring =\< 4 cm. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Measurable disease is not required
Patients who are status/post local excision or excisional biopsy procedure are eligible provided there was tumor involvement of the anal canal and/or anal verge prior to the reaction, if the margins were positive, and/or if the stage is T2N0 based on tumor size before the procedure. This means that patients with T1N0M0 anal margin squamous cell carcinoma who underwent surgical excision with negative margins and no involvement of the anal verge and/or anal canal are not eligible
Tumor size must be documented based on physical examination including digital rectal exam and/or anoscopy/proctoscopy within 4 weeks prior to Step 0 pre-registration
Patient's human immunodeficiency virus (HIV) status must be known and documented at baseline
- NOTE: For patients without a history of HIV infection, it is recommended (but not required) that updated HIV testing be performed within one year of study enrollment
Patients who are HIV-negative will be registered to Arm R. They must not have lymph nodes that are radiographically-concerning for cancer involvement using computed tomography (CT) and fludeoxyglucose F-18 (FDG) - positron emission tomography (PET)/CT-based criteria
- NOTE: Patients who are HIV-negative and meet the below criteria may proceed directly to Step 1 Randomization
- Patients will be considered to be lymph node (LN) positive and thereby not eligible in this study if the lymph nodes meet any of the following criteria:
  - Mesorectal, presacral, internal iliac or obturator LN with:
    - Short axis measuring > 5 mm based on CT/magnetic resonance imaging (MRI) OR
    - Morphologic features of irregular border or central necrosis if assessed on MRI and LN measures > 3 mm OR
    - FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
  - Internal Iliac and obturator LN with:
    - Short-axis measuring > 7 mm based on CT/MRI OR
    - Morphologic features of irregular border or central necrosis based on CT/MRI OR
    - FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
  - External Iliac and common Iliac:
    - Short-axis measuring > 10 mm based on CT/MRI OR
    - Morphologic features of irregular border or central necrosis based on CT/MRI OR
    - FDG uptake > blood pool (Deauville 3-5) based on FDG-PET/CT or PET/MRI
- Inguinal LN (superficial and deep) meeting any of the following criteria will be ineligible unless an fine needle aspiration (FNA) is performed and resulting cytology is negative.
  - Morphologic features of irregular border or central necrosis based on CT/MRI
  - FDG uptake > liver (Deauville 4) based on FDG-PET/CT.
  - Patients who are HIV-negative and have inguinal lymph nodes that do not meet the above criteria must undergo fine needle aspiration and have negative histology to be eligible
Patients who are HIV-positive will be registered to Arm S. They must meet the eligibility criteria below:
- A CD4 count >= 200
- Imaging submitted to ECOG-ACRIN for central review for confirmation of no lymph node involvement
- No history of acquired immunodeficiency syndrome (AIDS)-related complications within past year other than a history of low CD4+ T-cell count (> 200/mm\^3) prior to initiation of combination antiretroviral therapy
- Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer
- Patient MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Patients will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks
STEP 1 RANDOMIZATION
Patient must have met the eligibility criteria as outlined Step 0 Pre-registration
Patient must have Eastern Cooperative Oncology Group (ECOG) - American College of Radiology Imaging Network (ACRIN) performance status of 0-2
Patient must have no history of prior chemotherapy for this malignancy
Patients must not have undergone previous radiation to the pelvis such that overlapping radiation fields would be expected
Patient must not have had prior potentially curative surgery (i.e. abdominal-perineal resection) for carcinoma of the anus. However, patients who undergo local excision or excisional biopsy are eligible provided they meet inclusion criteria
Patients with T1N0M0 anal margin squamous cell carcinoma must not have undergone surgical excision with negative margins and no involvement of the anal verge and/or anal canal
Patient must not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs
Patient must not have intercurrent illness including, but not limited to, ongoing or active infection or psychiatric/social situations that, in the judgement of the investigator, would limit compliance with study requirements
Patient must not have had significant cardiovascular disease including myocardial infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary artery disease, symptomatic congestive heart failure, or uncontrolled cardiac arrhythmia within 6 months of Step 1 randomization
Patient must not have a history of a different malignancy unless they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk of recurrence
- Exceptions to this rule are individuals with cervical cancer in situ, non-melanoma skin cancers, and colon polyps
Patient must not have active inflammatory bowel disease (patients requiring current medical interventions or who are symptomatic)
Patients must not have an active autoimmune or connective tissue disease that has required systemic treatment in the past two years (i.e., with the use of modifying agents, corticosteroids, or immunosuppressive drugs) Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Patients who are on anti-coagulation with warfarin within 2 weeks prior to Step 1 randomization and are considering the use of capecitabine, must use an alternative anti-coagulant
- NOTE: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT)/international normalized ratio (INR) is \< 1.5
Patients who will receive capecitabine and are on Dilantin for a seizure disorder must have Dilantin levels checked weekly
Hemoglobin > 10 g/dL (within 2 weeks prior to Step 1 Randomization)
Platelets >= 100,000/mm\^3 (within 2 weeks prior to Step 1 Randomization)
Absolute neutrophil count >= 1500/mm\^3 (within 2 weeks prior to Step 1 Randomization)
Serum creatinine must be \< 1.5 X upper limit of normal (ULN), or calculated creatinine clearance must be > 50 ml/min (within 2 weeks prior to Step 1 Randomization)
Total bilirubin must be \< 2 X ULN (within 2 weeks prior to Step 1 Randomization)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 X institutional ULN (within 2 weeks prior to Step 1 Randomization)
Albumin >= 3.0 g/dL (within 2 weeks prior to Step 1 Randomization)
Women must not be pregnant or breast-feeding because the study treatment administered may cause harm to an unborn fetus or breastfeeding child. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to Step 1 Randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Women of childbearing potential and sexually active males must be strongly advised to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for at least 6 months after the completion of treatment

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 252 participants (estimated)

Study arms

Active comparator
Arm A (standard-dose chemoradiation)
Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/MRI or receive FDG and undergo PET/CT during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial.
Procedure: Biopsy · Procedure: Biospecimen Collection · Drug: Capecitabine · Procedure: Computed Tomography · Other: Fludeoxyglucose F-18 · Drug: Fluorouracil · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Drug: Mitomycin · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Experimental
Arm B (de-intensified chemoradiation)
Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/MRI or receive FDG and undergo PET/CT during baseline. Patients undergo CT or MRI on the trial. Patients also undergo tissue biopsy during screening and at the discretion of the treating physician. Additionally, patients undergo blood sample collection throughout the trial.
Procedure: Biopsy · Procedure: Biospecimen Collection · Drug: Capecitabine · Procedure: Computed Tomography · Other: Fludeoxyglucose F-18 · Drug: Fluorouracil · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Drug: Mitomycin · Procedure: Positron Emission Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

ProcedureBiopsy
Undergo tissue biopsy
Also known as: BIOPSY_TYPE, Bx
ProcedureBiospecimen Collection
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
DrugCapecitabine
Given PO
Also known as: Ro 09-1978/000, Xeloda
ProcedureComputed Tomography
Undergo PET/CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography
OtherFludeoxyglucose F-18
Receive FDG
Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
DrugFluorouracil
Given IV
Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757
RadiationIntensity-Modulated Radiation Therapy
Undergo IMRT
Also known as: IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy
ProcedureMagnetic Resonance Imaging
Undergo PET/MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
DrugMitomycin
Given IV
Also known as: Ametycine, Jelmyto, MITO, Mito-C, Mito-Medac, Mitocin, Mitocin-C, Mitolem, Mitomycin C, Mitomycin pyelocalyceal, Mitomycin-C, Mitomycin-X, Mitomycine C, Mitosol, Mitozytrex, Mutamycin, Mutamycine, NCI-C04706
ProcedurePositron Emission Tomography
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
OtherQuality-of-Life Assessment
Ancillary studies
Also known as: Quality of Life Assessment
OtherQuestionnaire Administration
Ancillary studies

What researchers measure

Primary outcomes

Disease control in the de-intensified chemoradiation therapy (CRT) arm
An event is local-regional failure, distant metastasis and chemoradiation-related death. Will determine if de-intensified chemoradiation achieves 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose CRT, as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. The co-primary endpoints of disease control and FIQoL will be formally assessed in a hierarchical manner with disease control being assessed first. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).
Time frame: Up to 2 years
Change in FIQoL in the de-intensified CRT arm
Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.
Time frame: Baseline up to 1 year

Secondary outcomes

Changes in patient-reported outcomes
Will compare changes as per Fecal Incontinence Severity Index \[FISI\], Patient Reported Outcomes Measurement Information System \[PROMIS\], International Index of Erectile Function \[IIEF\], Sexual Function-Vaginal Changes Questionnaire \[SVQ\], and Vaginal Assessment Scale \[VAS\]/Vulvar Assessment Scale \[VuAS\] instruments between the experimental and control arm. Quality of life analyses, will be compared between arms using a two-sample independent t-tests at a significance level of 0.05 and appropriate longitudinal models will be evaluated to assess the trajectory of HRQL endpoints over time and to evaluate those trajectories between treatment arms. Overall score and change from baseline will be summarized using mean and standard deviation at each time point for each arm.
Time frame: Baseline up to 5 years
Patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation)
Will be compared between experimental and control arm. The cumulative incidence method will be used to estimate local-regional and distant failure rates and the failure rates for the experimental treatment will be compared against the control using a failure specific log rank test.
Time frame: Up to 5 years
Disease control
Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).
Time frame: Up to 5 years
Effect of vaginal dilator use during radiation delivery on sexual function
Vaginal dilator use during radiation delivery will be correlated with sexual function.
Time frame: Up to 5 years
Change in serum total testosterone
Time frame: Baseline up to 12 months after radiation
Utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment
Will be validated as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified CRT is appropriate.
Time frame: Baseline
Incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil or capecitabine
Rates of grade 3+ adverse events (Common Terminology Criteria for Adverse Events \[CTCAE\], version \[v.\] 5) will be estimated using a binomial distribution along with their associated 95% confidence intervals and compared using Fisher's exact test between arms.
Time frame: Up to 5 years

Other outcomes

Overall survival
Will be compared between experimental and control arm. Will be estimated for all treatment arms using the Kaplan-Meier method (1958).
Time frame: Up to 5 years

Study locations

659 sites

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701, United States
Kingman Regional Medical Center
Kingman, Arizona 86401, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420, United States
PCR Oncology
Arroyo Grande, California 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Mercy Cancer Center - Carmichael
Carmichael, California 95608, United States
Mercy San Juan Medical Center
Carmichael, California 95608, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612, United States
UC San Diego Moores Cancer Center
La Jolla, California 92093, United States
Contra Costa Regional Medical Center
Martinez, California 94553-3156, United States
Mercy Cancer Center
Merced, California 95340, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304, United States
Mercy Cancer Center - Rocklin
Rocklin, California 95765, United States
Mercy Cancer Center - Sacramento
Sacramento, California 95816, United States
UC San Diego Medical Center - Hillcrest
San Diego, California 92103, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444, United States
Woodland Memorial Hospital
Woodland, California 95695, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012, United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909, United States
Memorial Hospital North
Colorado Springs, Colorado 80920, United States
Saint Francis Cancer Center
Colorado Springs, Colorado 80923, United States
Porter Adventist Hospital
Denver, Colorado 80210, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Southwest Oncology PC
Durango, Colorado 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113, United States
Swedish Medical Center
Englewood, Colorado 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113, United States
Poudre Valley Hospital
Fort Collins, Colorado 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado 80631, United States
Saint Anthony Hospital
Lakewood, Colorado 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120, United States
Littleton Adventist Hospital
Littleton, Colorado 80122, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
Medical Center of the Rockies
Loveland, Colorado 80538, United States
Parker Adventist Hospital
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830, United States
Smilow Cancer Hospital Care Center - Guilford
Guilford, Connecticut 06437, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510, United States
Yale University
New Haven, Connecticut 06520, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06473, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385, United States
Beebe Medical Center
Lewes, Delaware 19958, United States
Beebe South Coastal Health Campus
Millville, Delaware 19967, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713, United States
Helen F Graham Cancer Center
Newark, Delaware 19713, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718, United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971, United States
TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware 19973, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136, United States
Miami Cancer Institute
Miami, Florida 33176, United States
Health Central
Ocoee, Florida 34761, United States
Orlando Health Cancer Institute
Orlando, Florida 32806, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324, United States
Tampa General Hospital
Tampa, Florida 33606, United States
Cleveland Clinic-Weston
Weston, Florida 33331, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho 83617, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854, United States

Showing the first 100 of 659 sites.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04166318
Lead sponsor: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Nov 18, 2019
Start date: Jan 2, 2020
Primary completion: Dec 31, 2029 (estimated)
Completion: Dec 31, 2029 (estimated)
Last update: Sep 14, 2026

Study contacts

Jennifer A Dorth

principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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