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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002999 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with advanced cancer of the nasopharynx.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II |
| Estimated Enrollment: | 100 |
OBJECTIVES: I. Gather additional information and experience regarding the preferred treatment from clinical trial SWOG-8892, chemoradiation for patients with advanced nasopharyngeal cancers (NPC). II. Evaluate survival and progression-free survival and patterns of tumor failure in this new group of patients. III. Assess severe or lethal toxicities that may be encountered after this regimen is employed more widely. IV. Collect NPC tumor specimens for ongoing and future clinical correlative research.
OUTLINE: Patients receive cisplatin by intravenous infusion on day 1 over a 15-20 minute period. This is repeated every 21 days for the first three initial treatments. Patients also receive radiation therapy once daily five times a week during this cycle of treatment. Approximately three weeks after completion of the above treatment, patients are given cisplatin by intravenous infusion over 15-20 minutes as above but at a lower dose. On the same day as cisplatin infusion, patients receive fluorouracil by continuous intravenous infusion over 24 hours for 4 days in a row. This is repeated every 28 days for a total of 3 treatments. Patients are followed until death.
PROJECTED ACCRUAL: 100 patients will be accrued.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven nasopharyngeal carcinoma (excluding adenocarcinoma), stage III or IV with no evidence of distant metastatic disease (M0) No lung, bone, or liver metastases as proven within 42 days of registration by: -CT scan or nucleotide study of the chest or chest x-ray -liver and bone scan if alkaline phosphatase is greater than the institutional upper limit of normal (ULN), or if clinically indicated
PATIENT CHARACTERISTICS: Age: Any age Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.6 mg/dL AND/OR Creatinine clearance at least 50 mL/minute Other: Not pregnant or nursing Women/men of reproductive potential must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No previous chemotherapy to the primary site or nodes Endocrine therapy: Not specified Radiotherapy: No previous radiotherapy (except for nonmelanomatous skin cancer outside of the radiation therapy treatment volume) Surgery: No previous surgery to the primary site or nodes
Contacts and Locations| Study Chair: | Muhyi Al-Sarraf, MD, FRCPC, FACP | Providence Cancer Institute at Providence Hospital - Southfield Campus |
| Study Chair: | George L. Adams, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Study ID Numbers: | CDR0000065552, SWOG-S9715, E-S9715, RTOG-S9715 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002999 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III nasopharyngeal cancer stage IV nasopharyngeal cancer |
|
Antimetabolites Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Nasopharyngeal Carcinoma Immunologic Factors Pharyngeal Neoplasms Pharyngeal Diseases |
Immunosuppressive Agents Nasopharyngeal Neoplasms Cisplatin Head and Neck Neoplasms Fluorouracil Stomatognathic Diseases |
|
Antimetabolites Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pharyngeal Neoplasms Immunosuppressive Agents |
Pharyngeal Diseases Pharmacologic Actions Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Fluorouracil Nasopharyngeal Diseases Stomatognathic Diseases |
