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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentClosed18 and overNCI, OtherRTOG-1016
CDR0000695731, NCI-2011-02638, NCT01302834

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

NRG Oncology

Andy M. TrottiPrincipal Investigator

Maura Gillison, MD, PhDPrincipal Investigator

Trial Sites

U.S.A.
California
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 317-783-8918
Iowa
  Des Moines
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Andy M. Trotti Ph: 813-972-8424
  Email: trotti@moffitt.org
Missouri
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany G. Sleckman Ph: 913-948-5588
 Saint Louis University Cancer Center
 Bruce J. Walz Ph: 314-977-4440
North Carolina
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Andy M. Trotti Ph: 813-972-8424
  Email: trotti@moffitt.org
Pennsylvania
  Clairton
 UPMC Cancer Center at Jefferson Regional Medical Center
 James P Ohr Ph: 412-647-8073
  Greensburg
 UPMC Cancer Center - Arnold Palmer Pavilion
 James P Ohr Ph: 412-647-8073
  Moon Township
 UPMC - Moon
 James P Ohr Ph: 412-647-8073
  New Castle
 Jameson Memorial Hospital - North Campus
 James P Ohr Ph: 412-647-8073
  Pittsburgh
 St. Clair Memorial Hospital Cancer Center
 James P Ohr Ph: 412-647-8073
 UPMC - Shadyside
 James P Ohr Ph: 412-647-8073
 UPMC Cancer Center at UPMC Passavant
 James P Ohr Ph: 412-647-8073
 UPMC Cancer Center at UPMC St. Margaret
 James P Ohr Ph: 412-647-8073
Tennessee
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Andy M. Trotti Ph: 813-972-8424
  Email: trotti@moffitt.org
Canada
New Brunswick
  Saint John
 Saint John Regional Hospital
 Farah Naz Ph: 506-648-6890

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01302834
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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