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S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cisplatin
fluorouracil
radiation therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    May 22, 2015
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI), Eastern Cooperative Oncology Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002999
    Brief Title
    S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx
    Official Title
    S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI), Eastern Cooperative Oncology Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer
    Keywords
    stage III nasopharyngeal cancer, stage IV nasopharyngeal cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Drug
    Intervention Name(s)
    fluorouracil
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Muhyi Al-Sarraf, MD
    Organizational Affiliation
    Providence Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    George L. Adams, MD
    Organizational Affiliation
    Masonic Cancer Center, University of Minnesota
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    S9715, Chemotherapy and Radiation Therapy in Treating Patients With Advanced Cancer of the Nasopharynx

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