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

This study is ongoing, but not recruiting participants.

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
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Head and Neck Cancer   

ChemIDplus related topics:   Cisplatin    Fluorouracil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   S9715, Study of Patients With Advanced Nasopharyngeal Cancers Treated With Chemo-Radiotherapy, Phase II

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   100

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002999

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group

Investigators
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


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065552, SWOG-S9715, E-S9715, RTOG-S9715
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002999
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III nasopharyngeal cancer  
stage IV nasopharyngeal cancer  

Study placed in the following topic categories:
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Fluorouracil
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases
Pharyngeal Diseases
Nasopharyngeal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nasopharyngeal Diseases
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




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