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Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx Clinical research trials and Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx. Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx clinical trial. Participants frequently get the best healthcare available for their Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx  Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
For Condition: Oral Cancer,Throat Cancer
Status: No longer recruiting
Sponsor(s): UAB Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if radiation therapy is more effective with or without cetuximab for cancer of the oropharynx, hypopharynx, or larynx. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without cetuximab in treating patients who have stage III or stage IV cancer of the oropharynx, hypopharynx, or larynx.
Details: OBJECTIVES: - Compare the rate of locoregional disease control maintained for 1 year in patients with advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx treated with radiotherapy with or without concurrent cetuximab. - Compare the response rates, progression-free survival and overall survival rates, and quality of life in patients treated with these regimens. - Compare acute and late toxicity of these regimens in these patients. - Determine tumor epidermal growth factor receptor levels in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by Karnofsky performance status (60-80% vs 90-100%), nodal stage (N0 vs N+), tumor stage (T1-3 vs T4), and radiotherapy schedule (concurrent boost vs once daily vs twice daily). Patients are randomized to 1 of 2 treatment arms: - Patients undergo radiotherapy beginning on day 1. Patients are assigned to 1 of 3 radiotherapy groups: - Group 1: Patients undergo concurrent boost radiotherapy comprised of radiotherapy once daily 5 days a week for 3.5 weeks followed by radiotherapy twice daily 5 days a week for 2.5 weeks. - Group 2: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. - Group 3: Patients undergo radiotherapy twice daily 5 days a week for 6-6.5 weeks. - Arm II: Patients receive a test dose of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4 anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30 minutes after completion of test dose. Patients receive maintenance cetuximab IV over 1 hour on day 8. Maintenance cetuximab repeats every week for 7 courses. Beginning on day 8, patients undergo radiotherapy as in arm I concurrently with maintenance cetuximab. There must be an hour interval between the completion of cetuximab infusion and the start of any radiotherapy. Patients with more than N1 neck disease at initial presentation undergo neck dissection 4-8 weeks after the completion of radiotherapy. Quality of life is assessed before initiation of study therapy, at 8 weeks, and then every 4 months for 1 year. Patients are followed at 8 weeks, every 4 months for 2 years, and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 416 patients (208 per arm) will be accrued for this study within approximately 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven advanced squamous cell carcinoma of the oropharynx, hypopharynx, or larynx - Stage III OR - Stage IV without distant metastases - Measurable disease - Tumor tissue available for immunohistochemical assay of epidermal growth factor receptor expression PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 1 year Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT and SGPT no greater than 2 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min - Calcium normal Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Medically able to withstand a course of definitive radiotherapy - No medical or psychologic condition that would preclude informed consent or compliance - No other malignancy within the past 3 years except basal cell skin cancer or preinvasive carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior cetuximab or other murine monoclonal antibody Chemotherapy: - At least 3 years since prior systemic chemotherapy - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to head and neck - No other concurrent radiotherapy Surgery: - No prior surgery for indicator lesion except biopsy - Study radiotherapy must not be a part of a postoperative regimen after primary surgical resection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesBonner, Study Chair, UAB Comprehensive Cancer Center
ImClone Systems, Incorporated
Somerville, New Jersey, 08876
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Additional Information:
Study ID Numbers: CDR0000067468; UAB-9901,IMCL-CP02-9815,NCI-G99-1657
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004227
Other Oral Cancer Studies:
1. Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer
2. Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer
3. Radiation Therapy With or Without Epoetin alfa in Treating Patients With Head and Neck Cancer
4. Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer
5. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Related Studies:
Other Oral Cancer Clinical Trials
Other New Jersey Clinical Trials
Other Long Branch Clinical Trials
Radiation Therapy With or Without Cetuximab in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx, Hypopharynx, or Larynx
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