Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
This trial is active, not recruiting.
|Conditions||head and neck cancer, precancerous condition|
|Sponsor||Radiation Therapy Oncology Group|
|Collaborator||National Cancer Institute (NCI)|
|Start date||June 2011|
|End date||June 2020|
|Trial size||706 participants|
|Trial identifier||NCT01302834, CDR0000695731, NCI-2011-02638, RTOG-1016|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Anchorage, AK||Providence Cancer Center||no longer recruiting|
|Auburn, CA||Auburn Radiation Oncology||no longer recruiting|
|Burbank, CA||Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center||no longer recruiting|
|Cameron Park, CA||Radiation Oncology Centers - Cameron Park||no longer recruiting|
|Carmichael, CA||Mercy Cancer Center at Mercy San Juan Medical Center||no longer recruiting|
|Chico, CA||Enloe Cancer Center at Enloe Medical Center||no longer recruiting|
|Duarte, CA||City of Hope Comprehensive Cancer Center||no longer recruiting|
|La Jolla, CA||Rebecca and John Moores UCSD Cancer Center||no longer recruiting|
|Oakland, CA||Kaiser Permanente - Division of Research - Oakland||no longer recruiting|
|Rohnert Park, CA||Rohnert Park Cancer Center||no longer recruiting|
|Roseville, CA||Radiation Oncology Center - Roseville||no longer recruiting|
|Sacramento, CA||Mercy General Hospital||no longer recruiting|
|Sacramento, CA||Radiological Associates of Sacramento Medical Group, Incorporated||no longer recruiting|
|San Francisco, CA||UCSF Helen Diller Family Comprehensive Cancer Center||no longer recruiting|
|Santa Clara, CA 95051||not available||no longer recruiting|
|South San Francisco, CA||Kaiser Permanente Medical Center - South San Francisco||no longer recruiting|
|Vacaville, CA||Solano Radiation Oncology Center||no longer recruiting|
|Aurora, CO||Rocky Mountain Cancer Centers - Aurora||no longer recruiting|
|Boulder, CO||Boulder Community Hospital||no longer recruiting|
|Colorado Springs, CO||Penrose Cancer Center at Penrose Hospital||no longer recruiting|
|Denver, CO||Porter Adventist Hospital||no longer recruiting|
|Englewood, CO||Swedish Medical Center||no longer recruiting|
|Loveland, CO||McKee Medical Center||no longer recruiting|
|Thornton, CO||North Suburban Medical Center||no longer recruiting|
|New Britain, CT||George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus||no longer recruiting|
|Newark, DE||CCOP - Christiana Care Health Services||no longer recruiting|
|Dearfield Beach, FL||North Broward Medical Center||no longer recruiting|
|Jacksonville Beach, FL||Integrated Community Oncology Network||no longer recruiting|
|Jacksonville, FL||Baptist Cancer Institute - Jacksonville||no longer recruiting|
|Jacksonville, FL||Integrated Community Oncology Network at Southside Cancer Center||no longer recruiting|
|Jascksonville, FL||Baptist Medical Center South||no longer recruiting|
|Miami, FL||University of Miami Sylvester Comprehensive Cancer Center - Miami||no longer recruiting|
|Orange Park, FL||Integrated Community Oncology Network - Orange Park||no longer recruiting|
|Orlando, FL||Florida Hospital Cancer Institute at Florida Hospital Orlando||no longer recruiting|
|Orlando, FL||M.D. Anderson Cancer Center at Orlando||no longer recruiting|
|Palatka, FL||Florida Cancer Center - Palatka||no longer recruiting|
|Pensacola, FL||Sacred Heart Cancer Center at Sacred Heart Hospital||no longer recruiting|
|Saint Augustine, FL||Flagler Cancer Center||no longer recruiting|
|Tampa, FL||H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||no longer recruiting|
|Atlanta, GA||Georgia Cancer Center for Excellence at Grady Memorial Hospital||no longer recruiting|
|Atlanta, GA||Winship Cancer Institute of Emory University||no longer recruiting|
|Gainesville, GA||Northeast Georgia Medical Center||no longer recruiting|
|Savannah, GA||Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center||no longer recruiting|
|Savannah, GA||Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler||no longer recruiting|
|Arlington Heights, IL||Northwest Community Hospital||no longer recruiting|
|Chicago, IL||Creticos Cancer Center at Advocate Illinois Masonic Medical Center||no longer recruiting|
|Chicago, IL||John H. Stroger, Jr. Hospital of Cook County||no longer recruiting|
|Chicago, IL||Robert H. Lurie Comprehensive Cancer Center at Northwestern University||no longer recruiting|
|Chicago, IL||University of Chicago Cancer Research Center||no longer recruiting|
|Decatur, IL||Decatur Memorial Hospital Cancer Care Institute||no longer recruiting|
|Evanston, IL||Evanston Hospital||no longer recruiting|
|Maywood, IL||Cardinal Bernardin Cancer Center at Loyola University Medical Center||no longer recruiting|
|Springfield, IL||Cancer Institute at St. John's Hospital||no longer recruiting|
|Springfield, IL||Regional Cancer Center at Memorial Medical Center||no longer recruiting|
|Beech Grove, IN||St. Francis Hospital and Health Centers - Beech Grove Campus||no longer recruiting|
|Elkhart, IN||Elkhart General Hospital||no longer recruiting|
|Fort Wayne, IN||Parkview Regional Cancer Center at Parkview Health||no longer recruiting|
|Goshen, IN||Center for Cancer Care at Goshen General Hospital||no longer recruiting|
|Indianapolis, IN||Community Regional Cancer Care at Community Hospital East||no longer recruiting|
|Indianapolis, IN||Community Regional Cancer Care at Community Hospital North||no longer recruiting|
|Mishawaka, IN||Michiana Hematology-Oncology, PC - South Bend||no longer recruiting|
|Muncie, IN||Cancer Center at Ball Memorial Hospital||no longer recruiting|
|South Bend, IN||Memorial Hospital of South Bend||no longer recruiting|
|Ames, IA||McFarland Clinic, PC||no longer recruiting|
|Des Moines, IA||John Stoddard Cancer Center at Iowa Methodist Medical Center||no longer recruiting|
|Sioux City, IA||Siouxland Hematology-Oncology Associates, LLP||no longer recruiting|
|Kansas City, KS||Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center||no longer recruiting|
|Overland Park, KS||Kansas City Cancer Centers - Southwest||no longer recruiting|
|Prairie Village, KS||CCOP - Kansas City||no longer recruiting|
|Lexington, KY||Lucille P. Markey Cancer Center at University of Kentucky||no longer recruiting|
|Louisville, KY||James Graham Brown Cancer Center at University of Louisville||no longer recruiting|
|Baton Rouge, LA||Mary Bird Perkins Cancer Center - Baton Rouge||no longer recruiting|
|New Orleans, LA||CCOP - Ochsner||no longer recruiting|
|Scarborough, ME||Maine Center for Cancer Medicine and Blood Disorders - Scarborough||no longer recruiting|
|Baltimore, MD||Greenebaum Cancer Center at University of Maryland Medical Center||no longer recruiting|
|Baltimore, MD||St. Agnes Hospital Cancer Center||no longer recruiting|
|Burlington, MA||Lahey Clinic Medical Center - Burlington||no longer recruiting|
|Danvers, MA||NSMC Cancer Center - Peabody||no longer recruiting|
|Fall River, MA||Hudner Oncology Center at Saint Anne's Hospital - Fall River||no longer recruiting|
|Ann Arbor, MI||Saint Joseph Mercy Cancer Center||no longer recruiting|
|Battle Creek, MI||Battle Creek Health System Cancer Care Center||no longer recruiting|
|Detroit, MI||Josephine Ford Cancer Center at Henry Ford Hospital||no longer recruiting|
|Flint, MI||Genesys Hurley Cancer Institute||no longer recruiting|
|Grand Rapids, MI||Butterworth Hospital at Spectrum Health||no longer recruiting|
|Grand Rapids, MI||Lacks Cancer Center at Saint Mary's Health Care||no longer recruiting|
|Coon Rapids, MN||Mercy and Unity Cancer Center at Mercy Hospital||no longer recruiting|
|Edina, MN||Fairview Southdale Hospital||no longer recruiting|
|Fridley, MN||Mercy and Unity Cancer Center at Unity Hospital||no longer recruiting|
|Saint Louis Park, MN||Park Nicollet Cancer Center||no longer recruiting|
|St. Paul, MN||Regions Hospital Cancer Care Center||no longer recruiting|
|Pascagoula, MS||Regional Cancer Center at Singing River Hospital||no longer recruiting|
|Cape Girardeau, MO||Cancer Institute of Cape Girardeau, LLC||no longer recruiting|
|Kansas City, MO||Kansas City Cancer Centers - North||no longer recruiting|
|Kansas City, MO||Kansas City Cancer Centers - South||no longer recruiting|
|Saint Louis, MO||Barnes-Jewish West County Hospital||no longer recruiting|
|Saint Louis, MO||CCOP - St. Louis-Cape Girardeau||no longer recruiting|
|Saint Louis, MO||David C. Pratt Cancer Center at St. John's Mercy||no longer recruiting|
|Saint Louis, MO||Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||no longer recruiting|
|Springfield, MO||Hulston Cancer Center at Cox Medical Center South||no longer recruiting|
|Billings, MT||Billings Clinic - Downtown||no longer recruiting|
|Omaha, NE||Methodist Estabrook Cancer Center||no longer recruiting|
|Omaha, NE||Nebraska Medical Center||no longer recruiting|
|Reno, NV||Renown Institute for Cancer at Renown Regional Medical Center||no longer recruiting|
|Concord, NH||Payson Center for Cancer Care at Concord Hospital||no longer recruiting|
|Dover, NH||Seacoast Cancer Center at Wentworth - Douglass Hospital||no longer recruiting|
|Keene, NH||Kingsbury Center for Cancer Care at Cheshire Medical Center||no longer recruiting|
|Lebanon, NH||Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||no longer recruiting|
|Long Branch, NJ||Monmouth Medical Center||no longer recruiting|
|Sparta, NJ||Frederick R. and Betty M. Smith Cancer Treatment Center||no longer recruiting|
|Voorhees, NJ||Cancer Institute of New Jersey at Cooper - Voorhees||no longer recruiting|
|Albuquerque, NM||University of New Mexico Cancer Center||no longer recruiting|
|Binghamton, NY||Lourdes Regional Cancer Center||no longer recruiting|
|Rochester, NY||Highland Hospital of Rochester||no longer recruiting|
|Rochester, NY||James P. Wilmot Cancer Center at University of Rochester Medical Center||no longer recruiting|
|Asheville, NC||Mission Hospitals - Memorial Campus||no longer recruiting|
|Charlotte, NC||Blumenthal Cancer Center at Carolinas Medical Center||no longer recruiting|
|Greensboro, NC||Moses Cone Regional Cancer Center at Wesley Long Community Hospital||no longer recruiting|
|Kinston, NC||Kinston Medical Specialists||no longer recruiting|
|Pinehurst, NC||FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center||no longer recruiting|
|Akron, OH||Summa Center for Cancer Care at Akron City Hospital||no longer recruiting|
|Barberton, OH||Barberton Citizens Hospital||no longer recruiting|
|Cincinnati, OH||Charles M. Barrett Cancer Center at University Hospital||no longer recruiting|
|Cleveland, OH||Case Comprehensive Cancer Center||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Cancer Center at Fairview Hospital||no longer recruiting|
|Cleveland, OH||Cleveland Clinic Taussig Cancer Center||no longer recruiting|
|Columbus, OH||Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center||no longer recruiting|
|Maumee, OH||Northwest Ohio Oncology Center||no longer recruiting|
|Mayfield Heights, OH||Hillcrest Cancer Center at Hillcrest Hospital||no longer recruiting|
|Mentor, OH||Lake/University Ireland Cancer Center||no longer recruiting|
|Middleburg Heights, OH||Southwest General Health Center||no longer recruiting|
|Oregon, OH||St. Charles Mercy Hospital||no longer recruiting|
|Sylvania, OH||Flower Hospital Cancer Center||no longer recruiting|
|Toledo, OH||St. Anne Mercy Hospital||no longer recruiting|
|West Chester, OH||Precision Radiotherapy at University Pointe||no longer recruiting|
|Westlake, OH||UHHS Westlake Medical Center||no longer recruiting|
|Wooster, OH||Cancer Treatment Center||no longer recruiting|
|Oklahoma City, OK||Oklahoma University Cancer Institute||no longer recruiting|
|Tulsa, OK||Natalie Warren Bryant Cancer Center at St. Francis Hospital||no longer recruiting|
|Clackamas, OR||Clackamas Radiation Oncology Center||no longer recruiting|
|Medford, OR||Dubs Cancer Center at Rogue Valley Medical Center||no longer recruiting|
|Medford, OR||Providence Cancer Center at PMCC||no longer recruiting|
|Portland, OR||Knight Cancer Institute at Oregon Health and Science University||no longer recruiting|
|Portland, OR||Providence Cancer Center at Providence Portland Medical Center||no longer recruiting|
|Portland, OR||Providence St. Vincent Medical Center||no longer recruiting|
|Abington, PA||Rosenfeld Cancer Center at Abington Memorial Hospital||no longer recruiting|
|East Stroudsburg, PA||Dale and Frances Hughes Cancer Center at Pocono Medical Center||no longer recruiting|
|Gettysburg, PA||Adams Cancer Center||no longer recruiting|
|Hanover, PA||Cherry Tree Cancer Center||no longer recruiting|
|Langhorne, PA||St. Mary Regional Cancer Center||no longer recruiting|
|Philadelphia, PA||Fox Chase Cancer Center - Philadelphia||no longer recruiting|
|Reading, PA||McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center||no longer recruiting|
|York, PA||York Cancer Center at Apple Hill Medical Center||no longer recruiting|
|Charleston, SC||Hollings Cancer Center at Medical University of South Carolina||no longer recruiting|
|Greenville, SC||Cancer Centers of the Carolinas - Faris Road||no longer recruiting|
|Greenville, SC||CCOP - Greenville||no longer recruiting|
|Spartanburg, SC||Cancer Centers of the Carolinas - Spartanburg||no longer recruiting|
|Spartanburg, SC||Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||no longer recruiting|
|Rapid City, SD||Rapid City Regional Hospital||no longer recruiting|
|Nashville, TN||Vanderbilt-Ingram Cancer Center||no longer recruiting|
|Galveston, TX||University of Texas Medical Branch||no longer recruiting|
|Houston, TX||M. D. Anderson Cancer Center at University of Texas||no longer recruiting|
|Murray, UT||Jon and Karen Huntsman Cancer Center at Intermountain Medical Center||no longer recruiting|
|Ogden, UT||Val and Ann Browning Cancer Center at McKay-Dee Hospital Center||no longer recruiting|
|Provo, UT||Utah Valley Regional Medical Center - Provo||no longer recruiting|
|Salt Lake City, UT||Huntsman Cancer Institute at University of Utah||no longer recruiting|
|Salt Lake City, UT||Utah Cancer Specialists at UCS Cancer Center||no longer recruiting|
|Norfolk, VA||Sentara Cancer Institute at Sentara Norfolk General Hospital||no longer recruiting|
|Virginia Beach, VA||Coastal Cancer Center at Sentara Virginia Beach General Hospital||no longer recruiting|
|Bellingham, WA||St. Joseph Cancer Center||no longer recruiting|
|Seattle, WA||CCOP - Virginia Mason Research Center||no longer recruiting|
|Vancouver, WA||Northwest Cancer Specialists at Vancouver Cancer Center||no longer recruiting|
|Yakima, WA||North Star Lodge Cancer Center at Yakima Valley Memorial Hospital||no longer recruiting|
|Huntington, WV||Edwards Comprehensive Cancer Center at Cabell Huntington Hospital||no longer recruiting|
|Wheeling, WV||Schiffler Cancer Center at Wheeling Hospital||no longer recruiting|
|Appleton, WI||Theda Care Cancer Institute||no longer recruiting|
|Green Bay, WI||St. Mary's Hospital Medical Center - Green Bay||no longer recruiting|
|Green Bay, WI||St. Vincent Hospital Regional Cancer Center||no longer recruiting|
|La Crosse, WI||Gundersen Lutheran Center for Cancer and Blood||no longer recruiting|
|Madison, WI||University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||no longer recruiting|
|Marinette, WI||Bay Area Cancer Care Center at Bay Area Medical Center||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin Cancer Center||no longer recruiting|
|Milwaukee, WI||Veterans Affairs Medical Center - Milwaukee||no longer recruiting|
|Wausau, WI||University of Wisconcin Cancer Center at Aspirus Wausau Hospital||no longer recruiting|
|Winnipeg, Canada||CancerCare Manitoba||no longer recruiting|
|Montreal, Canada||McGill Cancer Centre at McGill University||no longer recruiting|
|Intervention model||parallel assignment|
time frame: From randomization to date of failure (death) or last follow-up. Analysis occurs after 219 failures have been reported.
time frame: From randomization to date of failure (local, regional or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome.
time frame: From randomization to date of failure (local or regional progression) or distant progression or death or last follow-up. Analysis occurs at the same time as the primary outcome.
time frame: From randomization to date of failure (distant progression) or local or regional progression or death or last follow-up. Analysis occurs at the same time as the primary outcome.
Acute toxicities (CTCAE v. 4) and overall toxicity burden at end of treatment and at 1, 3, and 6 months after completion of treatment
time frame: From start of treatment to 6 months after end of treatment.
Late toxicities (CTCAE v. 4) at 1, 2, and 5 years
time frame: From 6 months after end of treatment to 5 years after end of treatment.
Second primary cancers
time frame: From randomization to date of failure (second primary cancer) or death or last follow-up. Analysis occurs at the same time as the primary outcome.
Pattern of failure
time frame: From randomization to date of local, regional or distant progression or death or last follow-up. Analysis occurs at the same time as the primary outcome.
time frame: From randomization to 30 days after end of treatment.
Feeding tube rate at 1 year
time frame: From randomization to 1 year.
EORTC QLC-C30 at baseline, end of treatment, 3, 6, and 12 months from end of treatment.
time frame: From randomziation to 1 year after end of treatment.
EORTC QLQ-H&N35 at baseline, end of treatment, 3, 6, and 12 months from end of treatment.
time frame: From randomization to 1 year after end of treatment.
PRO-CTCAE-H&N at baseline, end of treatment, 3, 6, and 12 months from end of treatment.
time frame: From randomization to 1 year after end of treatement.
EQ-5D at baseline, end of treatment, 3, 6, and 12 months from end of treatment.
time frame: From randomization to 1 year after end of treatment.
Work Status Questionnaire at baseline, end of treatment, 3, 6, and 12 months.
time frame: From randomization to 1 year after end of treatment.
Dental status at baseline, 12, 24, 60 and 120 months from end of treatment.
time frame: From randomization to 10 years after end of treatment.
Hearing quality of life outcomes as measured by the HHIA-S at baseline, end of treatment and at 3, 6, and 12 months from end of treatment.
time frame: From randomization to 1 year after end of treatment.
Behavioral Risk Assessment Survey (BRASS) at baseline.
time frame: Prior to randomization.
Translational research analysis
time frame: From randomization to date of death or last follow-up.
Male or female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - 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) - No cancer from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal, or lip), nasopharynx, hypopharynx, or larynx, even if p16 positive - No carcinoma of the neck of unknown primary site origin (even if p16 positive) - Cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx - Clinical evidence should be documented; may consist of palpation, imaging, or endoscopic evaluation; and should be sufficient to estimate the size of the primary (for T stage) - No distant metastasis or adenopathy below the clavicles - Patients must be positive for p16, determined by the OSU Innovation Center CLIA lab prior to step 2 registration (randomization) - Paraffin-embedded cytology specimens are acceptable for p16 evaluation, but cytology smears are not - 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 - Clinical stage T1-2 N2a-N3 or T3-4 any N, including no distant metastases - No clinical stage T1-2 N0-1 - No simultaneous primaries or bilateral tumors PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - ANC ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable) - Bilirubin ≤ 2 mg/dL - AST or ALT ≤ 3 times upper limit of normal - Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min - Negative pregnancy test - 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 - Patients who are HIV-positive and have no prior AIDS-defining illness and have CD4 cells of at least 340/mm³ are eligible - HIV status must be known prior to registration - No multidrug resistance for HIV infection - Not seropositive for hepatitis B (hepatitis B surface antigen positive or anti-hepatitis B core antigen positive) or hepatitis C (anti-hepatitis C antibody positive) - Immunity to hepatitis B (anti-hepatitis B surface antibody positive) allowed - No prior invasive malignancy except non-melanoma skin cancer, or malignancy for which the patient has been disease-free for at least 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix) - No severe, active co-morbidity, defined as any of the following: - Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration - Transmural myocardial infarction within the last 6 months - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol - Immunocompromised patients - No prior allergic reaction to cisplatin or cetuximab PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior systemic chemotherapy for the study cancer - Prior chemotherapy for a different cancer allowed - No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields - No prior cetuximab or other anti-EGFR therapy - No concurrent amifostine as a radioprotector - No concurrent granulocyte colony-stimulating factor or erythropoietin
|Official title||Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer|
|Principal investigator||Andy M. Trotti, MD|
|Description||OBJECTIVES: Primary - To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival. Secondary - To monitor and compare progression-free survival for "safety". - To compare patterns of failure (locoregional vs distant). - To compare acute toxicity profiles (and overall toxicity burden). - To compare overall quality of life (QOL) short-term (< 6 months) and long-term (2 years). - To compare QOL Swallowing Domains short-term and long-term. - To compare clinician-reported versus patient-reported CTCAE toxicity events. - To explore differences in the cost effectiveness of cetuximab as compared to cisplatin. - To explore differences in work status and time to return to work. - To compare patient-reported changes in hearing. - To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years. - To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival. - To pilot CASI collection of patient reported outcomes in a cooperative group setting. - To determine whether specific molecular profiles are associated with overall or progression-free survival. - To investigate associations between changes in serum biomarkers or HPV-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs > 10 pack-years). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo image-guided intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks. Patients also receive high-dose cisplatin IV over 1-2 hours on days 1 and 22. - Arm II: Beginning 1 week prior to IMRT, patients receive cetuximab IV over 2 hours. Patients then receive cetuximab IV over 1 hour once weekly for 7 weeks. Patients undergo IMRT as in arm I. Tumor tissue and blood samples are collected at baseline and may also be collected at 3- and 6-month follow-up visits for correlative studies. Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year. After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.|
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