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S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II

Phase 2
Not Enrolling
Head and Neck Cancer

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Trial Information

S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II

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.

Inclusion Criteria

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
-liver scan if SGOT is greater than the institutional ULN

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Muhyi Al-Sarraf, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Institute at Providence Hospital - Southfield Campus


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III nasopharyngeal cancer
  • stage IV nasopharyngeal cancer
  • Head and Neck Neoplasms
  • Nasopharyngeal Neoplasms