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Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00408694
Recruitment Status : Completed
First Posted : December 7, 2006
Results First Posted : April 18, 2013
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells.

Condition or disease Intervention/treatment Phase
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 Radiation: 3-Dimensional Conformal Radiation Therapy Biological: Bevacizumab Drug: Cisplatin Drug: Fluorouracil Radiation: Intensity-Modulated Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil, and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.

SECONDARY OBJECTIVES:

I. Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen.

II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen.

III. Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer
Actual Study Start Date : December 13, 2006
Actual Primary Completion Date : December 15, 2011
Actual Study Completion Date : December 15, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (bevacizumab, cisplatin, fluorouracil, IMRT, 3D-CRT)

BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.

ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
Other Names:
  • 3-dimensional radiation therapy
  • 3D CONFORMAL RADIATION THERAPY
  • 3D CRT
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Biological: Bevacizumab
Given IV
Other Names:
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Avastin
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar FKB238
  • BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • Intensity-Modulated Radiotherapy



Primary Outcome Measures :
  1. Percentage of Patients With a Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year. [ Time Frame: From start of treatment to one year. ]
    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) 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.


Secondary Outcome Measures :
  1. Percentage of Patients With Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment After the First Year. [ Time Frame: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from day 366 to death or study termination whichever occurs first, up to 3.6 years. ]
    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) 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.

  2. Patient Tolerability to Each Component (Concurrent and Adjuvant) of the Protocol Treatment Regimen [ Time Frame: From start of treatment to end of treatment (approximately day 109). ]
    Evaluated in terms of protocol treatment delivery. For concurrent treatment, measured by the percentage of patients who received 2 or more cycles of cisplatin (CDDP) and bevacizumab (BV) during concurrent treatment with radiation therapy(RT) and who had RT scored by the study chair as no variation or minor variation. For adjuvant treatment, measured by the percentage of patients who received 2 or more cycles of CDDP and 5-FU and BV during the adjuvant treatment phase. Estimated using a binomial distribution along with their associated 95% confidence intervals.

  3. Death During or Within 30 Days of Discontinuation of Protocol Treatment. [ Time Frame: From start of treatment to 30 days after end of treatment (treatment ends approximately day 109). ]
    The percentage of patients dying during protocol treatment or within 30 days after the end of treatment. Estimated using a binomial distribution along with associated 95% confidence interval.

  4. One- and Two-year Distant Metastases-free Rates [ Time Frame: From registration to two years ]
    Distant metastasis is defined as clear evidence of distant metastases (lung, bone, brain, etc.); biopsy is recommended where possible. Distant metastasis-free rate estimated by cumulative incidence method with death considered a competing risk.

  5. One- and Two-year Loco-regional Progression-free Rates [ Time Frame: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. ]
    Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Local-regional progression-free rate estimated by cumulative incidence with death considered a competing risk.

  6. One- and Two-year Progression-free Survival Rates [ Time Frame: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. ]
    Progression-free survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is loco-regional or distant progression, or death due to any cause. Loco-regional progression is defined as an estimated increase in the size of the tumor (product of the perpendicular diameters of the two largest dimensions) of greater than 25%, taking as reference the smallest value of all previous measurements or appearance of new areas of malignant disease. Distant progression is defined as distant metastases.

  7. One- and Two-year Overall Survival Rates [ Time Frame: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from study registration to death or study termination whichever occurs first, up to 3.6 years. ]
    Overall survival rate estimated by Kaplan-Meier method along with 95% confidence interval. An event is death due to any cause.

  8. Percentage of Patients With Other Grade 3-5 Adverse Events Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment [ Time Frame: Analysis occurs after all patients have been on study for at least 2 years. Patients are followed from start of treatment to death or study termination whichever occurs first, up to 3.6 years. ]
    Estimated using a binomial distribution along with the 95% confidence interval. Adverse events (AE) 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed cancer of the nasopharynx based on biopsy of a primary lesion and/or lymph nodes

    • Histologic WHO types I-IIb/III
  • Stage IIB-IVB disease

    • No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
  • No distant metastases
  • Zubrod performance status 0-1
  • WBC ? 4,000/mm?
  • Hemoglobin ? 9.0 g/dL
  • Platelet count ? 100,000/mm?
  • Absolute neutrophil count ? 1,500/mm?
  • INR ? 1.5
  • aPTT ? 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ? 1.5 times ULN
  • ALT and AST ? 1.5 times ULN
  • Bilirubin ? 1.5 times ULN
  • Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
  • Urine protein:creatinine (UPC) ratio < 1.0

    • If UPC > 0.5, 24-hour urine protein must be < 1,000 mg
  • Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
  • Conductive hearing loss from tumor-related otitis media is allowed
  • No severe, active comorbidity, including any of the following:

    • Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the past 6 months
    • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
    • Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within the past 6 months
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
    • Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the past 12 months
    • Major medical or psychiatric illness that, in the opinion of the study investigator, would preclude study compliance
    • Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
    • History of significant weight loss (> 15% from baseline)
    • History of arterial thromboembolic events
    • Acquired immune deficiency syndrome
    • Transmural myocardial infarction
    • Cerebrovascular accident
    • Transient ischemic attack
    • Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance
  • No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • Nutritional and physical condition considered suitable for study treatment
  • No significant traumatic injury within the past 4 weeks
  • No history of allergic reaction to the study drugs
  • No baseline blood pressure > 150/100 mm Hg
  • No peripheral neuropathy ? grade 2
  • Not pregnant or nursing
  • Negative serum pregnancy test
  • Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
  • At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
  • No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies

    • More than 15 days since prior biopsies
  • More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
  • More than 4 weeks since prior major surgical procedures
  • No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • No prior bevacizumab or other vascular endothelial growth factor-targeting agents
  • No prior systemic chemotherapy for the study cancer

    • Prior chemotherapy for a different cancer allowed
  • No concurrent hematologic growth factors (e.g. filgrastim [G-CSF], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
  • No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
  • No concurrent prophylactic amifostine or pilocarpine
  • No other concurrent experimental therapeutic cancer treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408694


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States, 95603
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States, 95682
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Bay Area Breast Surgeons Inc
Emeryville, California, United States, 94608
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Highland General Hospital
Oakland, California, United States, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, United States, 95661
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States, 95819
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville, California, United States, 95687
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
Integrated Community Oncology Network-Florida Cancer Center Beaches
Jacksonville Beach, Florida, United States, 32250
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Integrated Community Oncology Network-Southside Cancer Center
Jacksonville, Florida, United States, 32207
Baptist Medical Center South
Jacksonville, Florida, United States, 32258
Baptist Hospital of Miami
Miami, Florida, United States, 33176
21st Century Oncology-Orange Park
Orange Park, Florida, United States, 32073
UF Cancer Center at Orlando Health
Orlando, Florida, United States, 32806
21st Century Oncology-Palatka
Palatka, Florida, United States, 32177
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, United States, 32086
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States, 46016
United States, Maryland
Union Hospital of Cecil County
Elkton, Maryland, United States, 21921
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Holland Community Hospital
Holland, Michigan, United States, 49423
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, United States, 49442
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Mississippi
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Saint Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri, United States, 63376
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Community Medical Center
Toms River, New Jersey, United States, 08755
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Beth Israel Medical Center
New York, New York, United States, 10003
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division
New York, New York, United States, 10025
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Clarion Hospital
Clarion, Pennsylvania, United States, 16214
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, United States, 18512
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States, 18301
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Upper Delaware Valley Cancer Center
Milford, Pennsylvania, United States, 18337
UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania, United States, 15108
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
UPMC Jameson
New Castle, Pennsylvania, United States, 16105
Radiation Therapy Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
UPMC Jefferson Regional Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15236
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, United States, 15401
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, United States, 15301
United States, South Carolina
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236
United States, West Virginia
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Nancy Lee Radiation Therapy Oncology Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00408694     History of Changes
Obsolete Identifiers: NCT00707096
Other Study ID Numbers: NCI-2009-00736
NCI-2009-00736 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RTOG-0615
CDR0000518526
RTOG 0615 ( Other Identifier: Radiation Therapy Oncology Group )
RTOG-0615 ( Other Identifier: CTEP )
U10CA021661 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2006    Key Record Dates
Results First Posted: April 18, 2013
Last Update Posted: January 30, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Bevacizumab
Fluorouracil
Endothelial Growth Factors
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunoglobulin G
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunologic Factors