CompletedNCT01333033Updated Apr 13, 2023Results posted

PET Scan Imaging in Assessing Response in Patients With Esophageal Cancer Receiving Combination Chemotherapy

A Phase 2 interventional study of Oxaliplatin and Leucovorin Calcium in Adenocarcinoma of the Gastroesophageal Junction and Esophageal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 68 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 257
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

RATIONALE: PET scans done during chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment.

PURPOSE: This randomized phase II trial is studying PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

Read the detailed description

OBJECTIVES:

Primary

To induce a complete pathologic response (pCR) rate of 20% in positron emission tomography (PET) scan non-responders treated with either induction FOLFOX or carboplatin/paclitaxel, who then crossover to the other regimen during radiotherapy.

Secondary

To compare PET/CT response between induction treatment arms.
To compare pCR between induction treatment arms among PET/CT scan responders.
To directly compare pCR between induction treatment arms among non-responders if both treatment regimens are found to be efficacious.
To determine 8-month progression-free survival (PFS) in PET/CT scan responders, and in non-responders treated with alternative crossover chemoradiotherapy.
Estimate the PFS and overall survival (OS) curves, overall and among PET responders and PET/CT non-responders by induction treatment.
To determine the rate of postoperative anastomotic leak after neoadjuvant chemotherapy followed by chemoradiation.
To evaluate immunohistochemistry and RT-PCR of ERCC1, and genetic polymorphisms of ERCC1, XPD, and XRCC1.
To evaluate status and levels of methylation of nine candidate biomarker genes as well as expression levels of selected specific microRNAs, which will be correlated with chemoradiation response.
To compare the quality of life (QOL) of responders and nonresponders (as determined by PET/CT scanning) to presurgical treatment for esophageal cancer, in terms of global QOL, physical symptoms, physical functioning, and emotional well-being.
To examine the association between OS and QOL in esophageal cancer patients treated with chemotherapy, chemoradiation therapy, and surgery.

OUTLINE: This is a multicenter study. Patients are stratified according to T-stage (T1-2 vs T3-4) and nodal status (N0 vs N+). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by ≥ 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent radiotherapy (RT) (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to arm II during RT.
Arm II: Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases ≥ 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to arm I during RT.

Within 4-10 weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgery at the discretion of the treating team.

Patients may undergo blood sample collection at baseline and periodically during study for correlative studies. Patients may also complete quality-of-life questionnaires at baseline and periodically during study.

After completion of study therapy, patients are followed up periodically for 5 years.

Conditions studied

Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer

Browse trials for

Keywords

adenocarcinoma of the gastroesophageal junction
adenocarcinoma of the esophagus
stage IB esophageal cancer
stage IIA esophageal cancer
stage IIB esophageal cancer
stage IIIA esophageal cancer
stage IIIB esophageal cancer
stage IIIC esophageal cancer

In context

Esophageal Neoplasms

1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.

This study's enrollment of 257 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Browse Alliance for Clinical Trials in Oncology studies →

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

Surgically resectable, histologically confirmed esophageal adenocarcinoma, including Siewert gastroesophageal (GE) junction adenocarcinomas types 1 and 2
T1N1-3M0 or T2-4NanyM0 as determined by endoscopic ultrasound (EUS) and PET/CT (histologic confirmation of lymph involvement is not required); all disease (tumor and nodes) must be both surgically resectable and capable of containment in a radiotherapy field; no T4 tumor with clear evidence of invasion of the vertebral column, heart, great vessels, or tracheobronchial tree
All patients must have locoregional staging determined by endoscopic ultrasound (EUS) if technically feasible; endoscopy reports or subsequent gastrointestinal (GI) clinic note should clearly state both the T and N stage
No evidence of distant metastases (as determined by EUS or PET/CT)
Patients with cervical, supraclavicular, or other nodal disease that is either not included in the radiation field or is not able to be resected at the time of esophagectomy are not eligible
Patient must have pre-resection tissue available for central pathology review, in case that the patient has a pCR at the time of surgical resection to confirm diagnosis
Patients must have an fludeoxyglucose F 18 (FDG)-avid tumor with a maximum standard uptake value (SUVmax) of >= 5.0 on baseline PET/CT scan of primary tumor; baseline PET/CT scan should be performed; if it is necessary to repeat baseline PET/CT scan, reimbursement information is available
No prior malignancy within 5 years of registration, with the exception of basal or squamous cell skin cancers, or in situ bladder or cervical cancer; patients with prior malignancy treated with surgery only and disease free for more than 5 years are eligible; however, no prior thoracic radiation therapy (RT) or abdominal RT or chemotherapy allowed
No known contraindication to the use of fluorouracil, taxanes, or platinum compounds
No history of severe hypersensitivity reaction to Cremophor EL
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patient must be non-pregnant and non-nursing; women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to randomization; women of child-bearing potential include any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35mIU/mL); even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential
Absolute neutrophil count (ANC) >= 1,500/μL
Platelet count >= 100,000/μL
Bilirubin =\< 1.5 times upper limit of normal (ULN)
Calculated creatinine clearance >= 60 mL/min
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 times ULN

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 257 participants (actual)

Study arms

Experimental
Arm I (FOLFOX regimen)
Patients receive modified FOLFOX-6 therapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously on days 1-5. Treatment repeats every 14 days for 3 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreased by \>= 35%) receive 3 additional courses of FOLFOX-6 therapy and undergo concurrent RT (3D-conformal or intensity-modulated) once daily, 5 days a week, for approximately 6 weeks. Patients without responsive disease (tumor metabolic activity did not decrease by 35%) cross over to Arm II during RT.
Drug: Oxaliplatin · Drug: Leucovorin Calcium · Drug: Fluorouracil · Drug: Carboplatin · Drug: Paclitaxel · Procedure: Positron Emission Tomography · Procedure: Computed Tomography · Radiation: Radiation Therapy
Experimental
Arm II (carboplatin + paclitaxel + radiation)
Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 2 courses. Patients then undergo PET/CT scan. Patients with responsive disease (tumor metabolic activity decreases \>= 35%) continue to receive carboplatin IV over 30 minutes and paclitaxel IV over 1 hour once weekly for 5 weeks and undergo RT (3D-conformal or intensity-modulated) once a day, 5 days a week, for approximately 6 weeks. Patients without responsive disease (metabolic activity did not decrease by 35%) cross over to Arm I during RT
Drug: Carboplatin · Drug: Paclitaxel · Radiation: Radiation Therapy

Interventions

DrugOxaliplatin
Given IV
DrugLeucovorin Calcium
Given IV
DrugFluorouracil
Given IV
DrugCarboplatin
Given IV
DrugPaclitaxel
Given IV
ProcedurePositron Emission Tomography
Undergo PET/CT scan
ProcedureComputed Tomography
Undergo PET/CT scan
RadiationRadiation Therapy
Undergo RT

What researchers measure

Primary outcomes

Complete Pathological Response (pCR) of PET/CT Non-responders
The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Time frame: Up to 5 years

Secondary outcomes

PET/CT Response Between Treatment Arms
A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as measured by maximum standardized uptake value (SUVmax).
Time frame: Up to 5 years
pCR Compared Between Induction Treatment Arms Among PET/CT Responders
A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as\> \>\> \>\> \>\> measured by maximum standardized uptake value (SUVmax). A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.
Time frame: Up to 5 years
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious
A Complete Pathological Response (pCR) is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor. A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.\> \>\>\> \> \>\>\> Among the patients who completed induction therapy and did not respond, the percentage of patients reporting a pCR in each arm were compared.
Time frame: Up to 5 years
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group
A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction. Among the patients who completed induction therapy and did not respond, the progression free survival in each arm were compared. PFS will be measured from study entry until documented progression or death from any cause. PFS will be estimated using the method of Kaplan and Meier.
Time frame: Up to 5 years

Results

Posted Nov 3, 2021

Participant flow

Participant flow — Overall Study
Milestone	FOLFOX Responder	FOLFOX Non-Responder	CP Responder	CP Non-Responder	CP No Cross-over	FOLFOX6 No Cross-over
Started	72	39	64	50	14	18
Completed	72	39	64	50	0	0
Not completed	0	0	0	0	14	18
Withdrew: Ineligible	0	0	0	0	6	8
Withdrew: Withdrawal by subject	0	0	0	0	4	2
Withdrew: Pet inevaluable	0	0	0	0	2	4
Withdrew: Adverse event	0	0	0	0	2	1
Withdrew: Progression	0	0	0	0	0	1
Withdrew: Md decision	0	0	0	0	0	2

Outcome measures

PrimaryComplete Pathological Response (pCR) of PET/CT Non-responders

The primary endpoint of this study is the percentage of PET/CT non-responders within each induction treatment group reporting a pCR. A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.

Time frame:: Up to 5 years
Reported as:: Number · percentage of participants with a pCR

Complete Pathological Response (pCR) of PET/CT Non-responders
percentage of participants with a pCR	FOLFOX Non-Responder	CP Non-Responder
Complete Pathological Response (pCR) of PET/CT Non-responders	17.95 (7.54 to 33.53)	20 (10.03 to 33.72)

Statistical analysis

FOLFOX Non-Responder vs CP Non-Responder · Fisher Exact · p = 1.0

SecondaryPET/CT Response Between Treatment Arms

A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as measured by maximum standardized uptake value (SUVmax).

Time frame:: Up to 5 years
Reported as:: Number · percentage of patients with a response

PET/CT Response Between Treatment Arms
percentage of patients with a response	FOLFOX Regimen	CP (Carboplatin + Paclitaxel + Radiation)
PET/CT Response Between Treatment Arms	64.86 (55.23 to 73.69)	56.14 (46.54 to 65.42)

SecondarypCR Compared Between Induction Treatment Arms Among PET/CT Responders

A PET/CT response to induction therapy is defined as metabolic activity of the tumor decreasing by \>=35%, as\> \>\> \>\> \>\> measured by maximum standardized uptake value (SUVmax). A pCR is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor.

Time frame:: Up to 5 years
Reported as:: Number · percentage of participants with a pCR

pCR Compared Between Induction Treatment Arms Among PET/CT Responders
percentage of participants with a pCR	FOLFOX Responder	CP (Carboplatin + Paclitaxel + Radiation) Responder
pCR Compared Between Induction Treatment Arms Among PET/CT Responders	40.28 (28.88 to 52.5)	14.06 (6.64 to 25.02)

SecondarypCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious

A Complete Pathological Response (pCR) is defined as having no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor. A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction.\> \>\>\> \> \>\>\> Among the patients who completed induction therapy and did not respond, the percentage of patients reporting a pCR in each arm were compared.

Time frame:: Up to 5 years
Reported as:: Number · percentage of participants with a pCR

pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious
percentage of participants with a pCR	FOLFOX Regimen Non-Responders	CP (Carboplatin + Paclitaxel + Radiation) Non-Responders
pCR Compared Among Non-responders Between Induction Treatment Arms if Treatment Regimens Are Found to be Efficacious	17.95 (7.54 to 33.53)	20 (10.03 to 33.72)

SecondaryProgression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group

A non-responder was defined as having a PET/CT SUV (standard uptake value) decrease of less than 35% after induction. Among the patients who completed induction therapy and did not respond, the progression free survival in each arm were compared. PFS will be measured from study entry until documented progression or death from any cause. PFS will be estimated using the method of Kaplan and Meier.

Time frame:: Up to 5 years
Reported as:: Median · months

Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group
months	FOLFOX Regimen Non-Responder	CP Non-Responder
Progression Free Survival (PFS) Among PET/CT Non-responders Within Each Induction Treatment Group	NA (27.8 to NA)	33.4 (17.2 to NA)

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
FOLFOX Responder	3/72 (4.2%)	3/72 (4.2%)	72/72 (100%)
FOLFOX Non-Responder	1/39 (2.6%)	1/39 (2.6%)	38/39 (97.4%)
CP Responder	2/64 (3.1%)	2/64 (3.1%)	63/64 (98.4%)
CP Non-Responder	4/49 (8.2%)	4/49 (8.2%)	46/49 (93.9%)
CP No Cross-over	0/9 (0%)	0/9 (0%)	9/9 (100%)
FOLFOX No Cross-over	0/5 (0%)	0/5 (0%)	4/5 (80%)

Most frequent serious events

Most frequent serious events
Event	FOLFOX Responder	FOLFOX Non-Responder	CP Responder	CP Non-Responder	CP No Cross-over	FOLFOX No Cross-over
Cardiac arrestCardiac disorders	0/72	1/39	0/64	1/49	0/9	0/5
Esophageal perforationGastrointestinal disorders	1/72	0/39	0/64	1/49	0/9	0/5
DyspneaRespiratory, thoracic and mediastinal disorders	0/72	0/39	0/64	1/49	0/9	0/5
Respiratory failureRespiratory, thoracic and mediastinal disorders	1/72	0/39	0/64	1/49	0/9	0/5
Esophageal anastomotic leakInjury, poisoning and procedural complications	0/72	0/39	1/64	0/49	0/9	0/5
Thromboembolic eventVascular disorders	0/72	0/39	1/64	0/49	0/9	0/5
Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	1/72	0/39	0/64	0/49	0/9	0/5

Most frequent other events

Showing 10 of 151

Most frequent other events
Event	FOLFOX Responder	FOLFOX Non-Responder	CP Responder	CP Non-Responder	CP No Cross-over	FOLFOX No Cross-over
NauseaGastrointestinal disorders	56/72	31/39	42/64	38/49	6/9	0/5
Platelet count decreasedInvestigations	44/72	25/39	44/64	25/49	2/9	1/5
DiarrheaGastrointestinal disorders	36/72	16/39	23/64	20/49	1/9	1/5
Neutrophil count decreasedInvestigations	24/72	18/39	30/64	15/49	4/9	0/5
VomitingGastrointestinal disorders	33/72	18/39	18/64	20/49	3/9	1/5
ParesthesiaNervous system disorders	32/72	16/39	11/64	12/49	0/9	0/5
DyspneaRespiratory, thoracic and mediastinal disorders	12/72	10/39	17/64	21/49	2/9	1/5
Lymphocyte count decreasedInvestigations	26/72	15/39	27/64	19/49	0/9	1/5
Sinus bradycardiaCardiac disorders	1/72	1/39	0/64	0/49	0/9	2/5
Infusion related reactionInjury, poisoning and procedural complications	0/72	0/39	0/64	0/49	0/9	2/5

Baseline characteristics

All participants who enrolled on this trial are included in this analysis.

Age, Continuous
Age, Continuous(years)	Arm I (FOLFOX Regimen)	Arm II (Carboplatin + Paclitaxel + Radiation)	Total
Median	62 (22 to 84)	64 (42 to 80)	64 (22 to 84)

Sex: Female, Male
Sex: Female, Male(Participants)	Arm I (FOLFOX Regimen)	Arm II (Carboplatin + Paclitaxel + Radiation)	Total
Female	16	14	30
Male	113	114	227

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm I (FOLFOX Regimen)	Arm II (Carboplatin + Paclitaxel + Radiation)	Total
Hispanic or Latino	1	3	4
Not Hispanic or Latino	126	124	250
Unknown or Not Reported	2	1	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm I (FOLFOX Regimen)	Arm II (Carboplatin + Paclitaxel + Radiation)	Total
American Indian or Alaska Native	0	2	2
Asian	3	3	6
Native Hawaiian or Other Pacific Islander	0	1	1
Black or African American	6	4	10
White	119	116	235
More than one race	0	0	0
Unknown or Not Reported	1	2	3

Region of Enrollment
Region of Enrollment(participants)	Arm I (FOLFOX Regimen)	Arm II (Carboplatin + Paclitaxel + Radiation)	Total
United States	129	128	257

Study locations

68 sites

Camino Medical Group - Treatment Center
Mountain View, California 94040, United States
Palo Alto Medical Foundation
Palo Alto, California 94301, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115, United States
Yale Cancer Center
New Haven, Connecticut 06520-8028, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia 20007, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii 96813, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii 96817-3169, United States
Kuakini Medical Center
Honolulu, Hawaii 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
Castle Medical Center
Kailua, Hawaii 96734, United States
Kauai Medical Clinic
Lihue, Hawaii 96766, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii 96701, United States
Oncare Hawaii, Incorporated - Pali Momi
‘Aiea, Hawaii 96701, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois 60611-3013, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois 60612-3785, United States
University of Chicago Cancer Research Center
Chicago, Illinois 60637-1470, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois 61615, United States
CCOP - Carle Cancer Center
Urbana, Illinois 61801, United States
McFarland Clinic, PC
Ames, Iowa 50010, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa 51101, United States
Union Hospital of Cecil County
Elkton, Maryland 21921, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan 48106-0995, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota 55101, United States
United Hospital
Saint Paul, Minnesota 55102, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi 39216, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi 39581, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri 63110, United States
Billings Clinic - Downtown
Billings, Montana 59107-7000, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska 68114, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey 08043, United States
NYU Cancer Institute at New York University Medical Center
New York, New York 10016, United States
Mount Sinai Medical Center
New York, New York 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065, United States
SUNY Upstate Medical University Hospital
Syracuse, New York 13210, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina 27599-7295, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina 28232-2861, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina 28233-3549, United States
Iredell Memorial Hospital
Statesville, North Carolina 28677, United States
MeritCare Broadway
Fargo, North Dakota 58102, United States
CCOP - MeritCare Hospital
Fargo, North Dakota 58122, United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210-1240, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma 73104, United States
Forbes Regional Hospital
Monroeville, Pennsylvania 15146, United States
Alle-Kiski Medical Center
Natrona Heights, Pennsylvania 15065, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania 19107-5541, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania 19140, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania 15212, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania 15232, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina 29303, United States
Mountainview Medical
Berlin Corners, Vermont 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont 05401, United States
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin 54701, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin 54449, United States
Saint Joseph's Hospital
Marshfield, Wisconsin 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin 54548, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin 54501, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin 54868, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin 54481, United States
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin 54481, United States
Diagnostic and Treatment Center
Weston, Wisconsin 54476, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin 54476, United States

References and documents

Publications

Goodman KA, Ou FS, Hall NC, Bekaii-Saab T, Fruth B, Twohy E, Meyers MO, Boffa DJ, Mitchell K, Frankel WL, Niedzwiecki D, Noonan A, Janjigian YY, Thurmes PJ, Venook AP, Meyerhardt JA, O'Reilly EM, Ilson DH. Randomized Phase II Study of PET Response-Adapted Combined Modality Therapy for Esophageal Cancer: Mature Results of the CALGB 80803 (Alliance) Trial. J Clin Oncol. 2021 Sep 1;39(25):2803-2815. doi: 10.1200/JCO.20.03611. Epub 2021 Jun 2. PubMed 34077237 ↗
Ku GY, Bains MS, Park DJ, Janjigian YY, Rusch VW, Rizk NP, Yoon SS, Millang B, Capanu M, Goodman KA, Ilson DH. Phase II study of bevacizumab and preoperative chemoradiation for esophageal adenocarcinoma. J Gastrointest Oncol. 2016 Dec;7(6):828-837. doi: 10.21037/jgo.2016.08.09. PubMed 28078107 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2011 to primary completion in Nov 2015, 52 months.

Results were first posted in Nov 2021, 6 years after primary completion.

Of 178 non-industry phase 2 interventional studies under Esophageal Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 82. This study's 52 months is close to that.

Counting every sponsor, half of 206 studies reached it within 55 months; a quarter within 32 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 7, 2011
First posted: Apr 11, 2011
StartActual: Jul 2011
Primary completionActual: Nov 2015
CompletionActual: Apr 1, 2023
Results first posted: Nov 3, 2021
Last update: Apr 13, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01333033
Lead sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Apr 11, 2011
Start date: Jul 2011
Primary completion: Nov 2015
Completion: Apr 1, 2023
Results posted: Nov 3, 2021
Last update: Apr 13, 2023

Study contacts

Karyn A. Goodman, MD

study chair · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Oxaliplatin · Leucovorin · Fluorouracil

Other studies in this condition

Esophageal Neoplasms →

Other studies from this sponsor

Alliance for Clinical Trials in Oncology →

Start the discussion