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TerminatedNCT00360971Updated Dec 26, 2017Results posted

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer

A Phase 3 interventional study of palifermin and cisplatin in Head and Neck Cancer, Mucositis and Pain, sponsored by Radiation Therapy Oncology Group. Terminated at 48 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-26.

Sponsored by Radiation Therapy Oncology Group · Phase 3, Interventional, and Supportive care

Why this study was terminated
Due to positive preliminary results from other palifermin studies.
Phase
Phase 3
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer.

PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days [15 weeks] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and chemotherapy.

Secondary

  • Compare incidence and time to onset of Grades 3 or 4 oral mucositis in patients treated with these regimens.
  • Compare overall and progression-free survival and time to second primary in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (III vs IVA or IVB), tumor site (oral cavity or oropharynx vs hypopharynx or larynx), and radiotherapy technique used on study (intensity-modulated radiotherapy [IMRT] vs 3-dimensional conformal radiotherapy [3D-CRT]). Patients are randomized to 1 of 2 treatment arms.

Mucositis, pain, and symptom burden are assessed at baseline, during radiotherapy, and post radiotherapy. Xerostomia is assessed at baseline, during radiotherapy, and several times after completion of study therapy.

After completion of study therapy, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 298 patients will be accrued for this study.

02

Conditions studied

  • Head and Neck Cancer
  • Mucositis
  • Pain
  • Radiation Toxicity

Keywords

  • mucositis
  • pain
  • radiation toxicity
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 21 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Radiation Therapy Oncology Group is the lead sponsor of 154 studies on the registry; none are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  1. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;

  2. Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy;

    -2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy;

  3. Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry.

  4. Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup:

    • 4.1 History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to registration;
    • 4.2 Chest x-ray (or Chest CT scan) within 6 weeks prior to registration;
    • 4.3 MRI or CT scan with contrast of tumor site within 6 weeks prior to registration;
    • 4.4 Assessment of mucositis and xerostomia within 2 weeks prior to registration;
  5. Zubrod Performance Status 0-1;
  6. Age > 18;

  7. Adequate bone marrow function, defined as follows:

    • 7.1 Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
    • 7.2 Platelets > 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
    • 7.3 Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.)
  8. Adequate hepatic function with bilirubin \< 1.5 mg/dl, AST or ALT \< 2 x ULN within 2 weeks prior to registration;

  9. Adequate renal function with serum creatinine \< 1.5 mg/dl and creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:

    CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)

  10. Normal serum calcium or normal corrected serum calcium within 2 weeks prior to registration; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) + patient's measured calcium (mg/dl);
  11. Serum pregnancy test for women of childbearing potential within 2 weeks prior to registration;
  12. Women of childbearing potential and male participants must practice adequate contraception.
  13. Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
  14. Patient must sign study specific informed consent prior to study entry.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of prior head and neck squamous cancer are ineligible;
  2. Stage IVC (AJCC, 6th edition) [Any T, Any N, M1] or distant metastases at protocol study entry; T1N1M0 patients are excluded.
  3. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
  4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3.
  5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
  6. Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.

  7. Severe, active co-morbidity, defined as follows:

    • 7.1 Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV (see Appendix II);
    • 7.2 Transmural myocardial infarction within the last 6 months;
    • 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
    • 7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
    • 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
    • 7.6 Patients known to be sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV);
    • 7.7 Patients known to be sero-positive for human immunodeficiency virus (HIV) or patients with Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with HIV or AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
    • 7.8 A history of pancreatitis.
  8. Collagen vascular disease, such as scleroderma, as this disease is thought to predispose patients to increased risk for radiation-associated toxicities;
  9. Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin;
  10. Prior allergic reaction or known sensitivity to any of the agents administered during dosing, including E. coli-derived products, such as Nutropin®, Neupogen®, Humulin®, Roferon®; Neumega®, Neulasta®), IntronA®, Betaseron®;
  11. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Palifermin

    Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.

    Biological: palifermin · Drug: cisplatin · Procedure: neck dissection · Radiation: radiation therapy

  • Placebo comparator
    Placebo

    Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.

    Drug: cisplatin · Other: placebo · Procedure: neck dissection · Radiation: radiation therapy

Interventions

  • Biologicalpalifermin

    Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.

  • Drugcisplatin

    Patients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course.

  • Otherplacebo

    Four doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.

  • Procedureneck dissection

    A neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline.

  • Radiationradiation therapy

    A radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment.

06

What researchers measure

Primary outcomes

  1. Duration of Oral Mucositis as Measured in Terms of Days

    Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.

    Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

Secondary outcomes

  1. Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale

    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

  2. Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale

    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Time frame: Twice-weekly from start of treatment up to 15 weeks after the start of treatment.

  3. Overall Survival

    An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.

    Time frame: From randomization to maximum follow-up at time of analysis of 21 months

  4. Progression-free Survival

    An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.

    Time frame: From randomization to maximum follow-up at time of analysis of 21 months

  5. Time to Second Primary Tumor

    An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.

    Time frame: From randomization to maximum follow-up at time of analysis of 21 months

07

Results

Posted May 15, 2014
Limitations and caveats
This study terminated early with 21 subjects accrued out of 298 planned, therefore no statistical testing was performed. The termination was decided due to positive preliminary results from other palifermin studies.

Participant flow

Participant flow — Overall Study
MilestonePlaceboPalifermin
Started1011
Completed1011
Not completed00

Outcome measures

PrimaryDuration of Oral Mucositis as Measured in Terms of Days

Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.

Time frame:
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Reported as:
Mean · Days
Duration of Oral Mucositis as Measured in Terms of Days
DaysPlaceboPalifermin
Duration of Oral Mucositis as Measured in Terms of Days32 ± 2413 ± 23
SecondaryNumber of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Time frame:
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Reported as:
Count of participants · Participants
Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale
ParticipantsPlaceboPalifermin
Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale84
SecondaryTime to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale

Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Time frame:
Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
Reported as:
Mean · days
Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
daysPlaceboPalifermin
Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale48 ± 1041 ± 6
SecondaryOverall Survival

An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.

Time frame:
From randomization to maximum follow-up at time of analysis of 21 months
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsPlaceboPalifermin
Overall Survival20
SecondaryProgression-free Survival

An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.

Time frame:
From randomization to maximum follow-up at time of analysis of 21 months
Reported as:
Count of participants · Participants
Progression-free Survival
ParticipantsPlaceboPalifermin
Progression-free Survival20
SecondaryTime to Second Primary Tumor

An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.

Time frame:
From randomization to maximum follow-up at time of analysis of 21 months
Reported as:
Count of participants · Participants
Time to Second Primary Tumor
ParticipantsPlaceboPalifermin
Time to Second Primary Tumor00

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—8/10 (80%)9/10 (90%)
Palifermin—5/11 (45.5%)11/11 (100%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventPlaceboPalifermin
MucositisGastrointestinal disorders8/104/11
DehydrationMetabolism and nutrition disorders3/102/11
Weight decreasedInvestigations0/103/11
NauseaGastrointestinal disorders2/100/11
AnorexiaMetabolism and nutrition disorders2/100/11
Dry mouthGastrointestinal disorders1/100/11
DysphagiaGastrointestinal disorders1/101/11
Vomiting NOSGastrointestinal disorders1/100/11
Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L): AppendixInfections and infestations1/100/11
Metabolic/laboratory - Other:Investigations1/100/11
Most frequent other events
Showing 10 of 88
Most frequent other events
EventPlaceboPalifermin
Dry mouthGastrointestinal disorders7/109/11
MucositisGastrointestinal disorders2/107/11
Weight decreasedInvestigations5/107/11
DysgeusiaNervous system disorders6/105/11
DysphagiaGastrointestinal disorders3/106/11
FatigueGeneral disorders5/102/11
Leukopenia NOSInvestigations5/103/11
HemoglobinBlood and lymphatic system disorders4/105/11
ConstipationGastrointestinal disorders4/102/11
AnorexiaMetabolism and nutrition disorders4/104/11

Baseline characteristics

All eligible patients.

Age, Continuous
Age, Continuous(years)PlaceboPaliferminTotal
Median52 (35 to 82)55 (48 to 67)55 (35 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboPaliferminTotal
Female011
Male101020
08

Study locations

48 sites
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259-5499, United States
  • Auburn Radiation Oncology
    Auburn, California 95603, United States
  • Providence Saint Joseph Medical Center - Burbank
    Burbank, California 91505, United States
  • Radiation Oncology Centers - Cameron Park
    Cameron Park, California 95682, United States
  • Mercy Cancer Center at Mercy San Juan Medical Center
    Carmichael, California 95608, United States
  • Enloe Cancer Center at Enloe Medical Center
    Chico, California 95926, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • USC/Norris Comprehensive Cancer Center and Hospital
    Los Angeles, California 90089-9181, United States
  • Radiation Oncology Center - Roseville
    Roseville, California 95661, United States
  • Radiological Associates of Sacramento Medical Group, Incorporated
    Sacramento, California 95815, United States
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • Torrance Memorial Medical Center
    Torrance, California 90509, United States
  • Solano Radiation Oncology Center
    Vacaville, California 95687, United States
  • CCOP - Christiana Care Health Services
    Newark, Delaware 19713, United States
  • Saint John's Cancer Center at Saint John's Medical Center
    Anderson, Indiana 46016, United States
  • St. Agnes Hospital Cancer Center
    Baltimore, Maryland 21229, United States
  • Barbara Ann Karmanos Cancer Institute
    Detroit, Michigan 48201-1379, United States
  • Dickinson County Healthcare System
    Iron Mountain, Michigan 49801, United States
  • Borgess Medical Center
    Kalamazoo, Michigan 49001, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007-3731, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • William Beaumont Hospital - Royal Oak Campus
    Royal Oak, Michigan 48073, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • CentraCare Clinic - River Campus
    Saint Cloud, Minnesota 56303, United States
  • Regional Cancer Center at Singing River Hospital
    Pascagoula, Mississippi 39581, United States
  • Great Falls Clinic - Main Facility
    Great Falls, Montana 59405, United States
  • Cancer Institute of New Jersey at Cooper University Hospital - Camden
    Camden, New Jersey 08103, United States
  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
    Vineland, New Jersey 08360, United States
  • Cancer Institute of New Jersey at Cooper - Voorhees
    Voorhees, New Jersey 08043, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Leo W. Jenkins Cancer Center at ECU Medical School
    Greenville, North Carolina 27835-6028, United States
  • McDowell Cancer Center at Akron General Medical Center
    Akron, Ohio 44307, United States
  • Summa Center for Cancer Care at Akron City Hospital
    Akron, Ohio 44309-2090, United States
  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
    Salem, Ohio 44460, United States
  • Cancer Treatment Center
    Wooster, Ohio 44691, United States
  • Oklahoma University Cancer Institute
    Oklahoma City, Oklahoma 73104, United States
  • Sharon Regional Cancer Care Center- Hermitage
    Hermitage, Pennsylvania 16148, United States
  • Intercommunity Cancer Center
    Monroeville, Pennsylvania 15146, United States
  • Alle-Kiski Medical Center
    Natrona Heights, Pennsylvania 15065, United States
  • Allegheny Cancer Center at Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Somerset Oncology Center
    Somerset, Pennsylvania 15501, United States
  • Mount Nittany Medical Center
    State College, Pennsylvania 16803, United States
  • Johnson City Medical Center Hospital
    Johnson City, Tennessee 37604, United States
  • M. D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030-4009, United States
  • Schiffler Cancer Center at Wheeling Hospital
    Wheeling, West Virginia 26003, United States
  • St. Vincent Hospital Regional Cancer Center
    Green Bay, Wisconsin 54307-3508, United States
  • Bay Area Cancer Care Center at Bay Area Medical Center
    Marinette, Wisconsin 54143, United States
  • Cross Cancer Institute at University of Alberta
    Edmonton, Alberta T6G 1Z2, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00360971
Lead sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 7, 2006
Start date
Jul 2006
Primary completion
May 2008
Completion
Feb 2009
Results posted
May 15, 2014
Last update
Dec 26, 2017

Study contacts

David I. Rosenthal, MD
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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