![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052429 |
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: adjuvant therapy Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Study of Dose-Painting Using Intensity Modulated Radiation Therapy Plus Chemotherapy in Patients With Stage II-IVB Nasopharyngeal Carcinoma |
Estimated Enrollment: | 74 |
Study Start Date: | September 2002 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Cohorts of 10 patients receive the following treatment to assess for dose-limiting toxicity.
Phase I
In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II.
Phase II
PROJECTED ACCRUAL: Approximately 10-74 patients (10-20 for phase I and 54 for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed nasopharyngeal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Memorial Sloan - Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Suzanne Wolden, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Suzanne Wolden ) |
Study ID Numbers: | CDR0000258423, MSKCC-02077, NCI-H02-0101 |
Study First Received: | January 24, 2003 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00052429 |
Health Authority: | United States: Federal Government |
stage II lymphoepithelioma of the nasopharynx stage II squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx |
stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx |
Epidermoid carcinoma Nasopharyngeal carcinoma Cisplatin Fluorouracil Squamous cell carcinoma |
Head and Neck Neoplasms Carcinoma, squamous cell Carcinoma, Squamous Cell Carcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |