|
|
|
|
|
|
Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00113399 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) and giving them with radiation therapy may kill more tumor cells. It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery.
Condition | Intervention | Phase |
Head and Neck Cancer |
Drug: cisplatin Drug: docetaxel Drug: filgrastim Drug: fluorouracil Drug: paclitaxel Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Cancer Head and Neck Cancer |
ChemIDplus related topics: | Filgrastim Docetaxel Cisplatin Paclitaxel Fluorouracil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial for Locally Recurrent, Previously Irradiated Head and Neck Cancer: Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone |
Estimated Enrollment: | 240 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm II: Patients receive 1 of the following cisplatin-based* regimens at the discretion of the treating physician:
NOTE: *Carboplatin may be substituted for cisplatin in patients with creatinine clearance < 50 mL/min or in patients who experience grade 2 or 3 neurotoxicity.
For all regimens, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond documentation of CR.
Quality of life is assessed at baseline and then at 3, 6, 12, 24, and 36 months.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 240 patients (120 per treatment arm) will be accrued for this study within 5½ years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx, including any of the following histologic variants:
Original or second primary tumor
Unresectable disease
Must have had prior radiotherapy for SCC of the head and neck with > 75% of the present tumor volume in areas irradiated at doses ≥ 45 Gy but ≤ 75 Gy
First recurrence occurred > 6 months after completion of radiotherapy
No distant metastases by history or physical examination, chest CT scan, and CT scan or MRI of the tumor site
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior systemic chemotherapy for recurrent SCC of the head and neck
Endocrine therapy
Radiotherapy
Surgery
Other
Show 125 Study Locations |
Radiation Therapy Oncology Group |
National Cancer Institute (NCI) |
Principal Investigator: | Stuart J. Wong, MD | Medical College of Wisconsin |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000429480, RTOG-0421, ECOG-R0421 |
First Received: | June 7, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00113399 |
Health Authority: | United States: Federal Government |
|
|
|
|
|
|