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NCT01302834

PHASE3

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

Sponsor: Radiation Therapy Oncology Group

View on ClinicalTrials.gov

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, 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. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Official title: Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

987

Start Date

2011-06

Completion Date

2025-09-04

Last Updated

2026-07-20

Healthy Volunteers

Conditions

Head and Neck Cancer Precancerous Condition

Interventions

BIOLOGICAL

cetuximab

400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks

DRUG

cisplatin

100 mg/m2 IV on days 1 and 22 of IMRT

RADIATION

IMRT

35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Inclusion Criteria: 1. Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). 2. Patients must be positive for p16, determined by central review prior to randomization. 3. Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations. Tonsillectomy or local excision of the primary without removal of nodal disease is permitted, as is excision removing gross nodal disease but with intact primary site. Limited neck dissections retrieving ≤ 4 nodes are permitted and considered as non-therapeutic nodal excisions. Fine needle aspirations of the neck are insufficient due to limited tissue for retrospective central review. Biopsy specimens from the primary or nodes measuring at least 3-5 mm are required. 4. Clinical stage T1-2, N2a-N3 or T3-4, any N (AJCC, 7th ed.; see Appendix III), including no distant metastases, based upon the following minimum diagnostic workup: * General history and physical examination by a radiation oncologist and medical oncologist within 8 weeks prior to registration; * Examination by an ear, nose, and throat (ENT) or head and neck surgeon, including laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) within 8 weeks prior to registration; * One of the following combinations of imaging is required within 8 weeks prior to registration: 1. A computerized tomography (CT) scan of the neck (with contrast) and a chest CT scan (with or without contrast); 2. or a magnetic resonance imaging (MRI) scan of the neck (with contrast) and a chest CT scan (with or without contrast); 3. or a CT scan of neck (with contrast) and a positron emission tomography (PET)/CT of neck and chest (with or without contrast); 4. or an MRI of the neck (with contrast) and a PET/CT of neck and chest (with or without contrast). Note: A CT scan of neck and/or a PET/CT performed for radiation planning and read by a radiologist may serve as both staging and planning tools. 5. Zubrod Performance Status 0-1 within 2 weeks prior to registration 6. Age ≥ 18; 7. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function, defined as follows: * Absolute neutrophil count (ANC) \> 1,500 cells/mm3; * Platelets \> 100,000 cells/mm3; * Hemoglobin (Hgb) \> 8.0 g/dl; Note: The use of transfusion or other intervention to achieve Hgb \> 8.0 g/dl is acceptable. 8. Adequate hepatic function, defined as follows: * Bilirubin \< 2 mg/dl within 2 weeks prior to registration; * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x the upper limit of normal within 2 weeks prior to registration; 9. Adequate renal function, defined as follows: • Serum creatinine \< 1.5 mg/dl within 2 weeks prior to registration or creatinine clearance (CCr) ≥ 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 (CCr male) 10. Patients must provide their smoking history (for stratification) via the computer-assisted self interview (CASI) head and neck risk factor survey tool. 11. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; 12. Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until at least 60 days following the last study treatment. 13. Patients who are human immunodeficiency virus (HIV) positive but have no prior acquired immune deficiency syndrome (AIDS) -defining illness and have CD4 cells of at least 350/mm3 are eligible. Patient HIV status must be known prior to registration. Patients must not be sero-positive for Hepatitis B (Hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or sero-positive for Hepatitis C (anti-Hepatitis C antibody positive). However, patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B). HIV-positive patients must not have multi-drug resistant HIV infection or other concurrent AIDS-defining conditions. 14. Patient must provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required, central p16 review and consent to participate in the computer-assisted self interview (CASI) survey questions regarding smoking history. Exclusion Criteria: 1. Cancers considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive, are excluded. Carcinoma of the neck of unknown primary site origin (even if p16 positive) are excluded from participation. 2. Stage T1-2, N0-1; 3. Distant metastasis or adenopathy below the clavicles; 4. Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that removes all clinically and radiographically evident disease. 5. Simultaneous primaries or bilateral tumors; 6. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible); 7. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable; 8. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 9. Severe, active co-morbidity, defined as follows: * 9.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; * 9.2 Transmural myocardial infarction within the last 6 months; * 9.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * 9.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration; * 9.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. * 9.6 Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition with immune compromise greater than that noted in Section 3.1.13; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. 10. 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. 11. Prior allergic reaction to cisplatin or cetuximab; 12. Prior cetuximab or other anti-EGFR therapy.

Locations (185)

Providence Cancer Center

Anchorage, Alaska, United States

Auburn Radiation Oncology

Auburn, California, United States

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Burbank, California, United States

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Enloe Cancer Center at Enloe Medical Center

Chico, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Kaiser Permanente - Division of Research - Oakland

Oakland, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Radiation Oncology Center - Roseville

Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Santa Clara, California, United States

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Solano Radiation Oncology Center

Vacaville, California, United States

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, United States

Boulder Community Hospital

Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Porter Adventist Hospital

Denver, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

McKee Medical Center

Loveland, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

North Broward Medical Center

Dearfield Beach, Florida, United States

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Integrated Community Oncology Network at Southside Cancer Center

Jacksonville, Florida, United States

Integrated Community Oncology Network

Jacksonville Beach, Florida, United States

Baptist Medical Center South

Jascksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Integrated Community Oncology Network - Orange Park

Orange Park, Florida, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Florida Cancer Center - Palatka

Palatka, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, United States

Flagler Cancer Center

Saint Augustine, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, United States

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Northwest Community Hospital

Arlington Heights, Illinois, United States

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Evanston Hospital

Evanston, Illinois, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Elkhart General Hospital

Elkhart, Indiana, United States

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, United States

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, United States

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, United States

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

McFarland Clinic, PC

Ames, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, United States

CCOP - Kansas City

Prairie Village, Kansas, United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, United States

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

St. Agnes Hospital Cancer Center

Baltimore, Maryland, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

NSMC Cancer Center - Peabody

Danvers, Massachusetts, United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, United States

Kansas City Cancer Centers - South

Kansas City, Missouri, United States

Kansas City Cancer Centers - North

Kansas City, Missouri, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Barnes-Jewish West County Hospital

St Louis, Missouri, United States

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, United States

Billings Clinic - Downtown

Billings, Montana, United States

And 85 more locations on ClinicalTrials.gov

Clinical Research Directory

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (185)