S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known whether giving combination chemotherapy together with radiation therapy is more effective than giving cisplatin together with radiation therapy in treating cancer of the oropharynx.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and radiation therapy to see how well they work compared to cisplatin and radiation therapy in treating patients with stage III or stage IV cancer of the oropharynx.
|Head and Neck Cancer||Drug: cisplatin Drug: docetaxel Drug: 5-fluorouracil Procedure: surgery Radiation: radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Trial of Standard Fractionation Radiation and Concurrent Single Agent Cisplatin, With and Without Docetaxel, Cisplatin, and 5-Fluorouracil Induction Chemotherapy, in Patients With Advanced Oropharyngeal Squamous Cell Cancer|
- Survival at 2 years [ Time Frame: 2 years ]
- Progression-free survival by FACT-HN CTCAE v 3.0 at 2 years [ Time Frame: 2 years ]
- Toxicity by CTCAE v 3.0 after induction chemotherapy or after chemotherapy and radiotherapy [ Time Frame: after chemotherapy ]
- Incidence of surgical resection [ Time Frame: after treatment ]
- Site of relapse [ Time Frame: at relapse ]
- Quality of life by FACT-HN week 19 after first and second registration date (arm 1) [ Time Frame: after first and second registrations ]
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: cisplatin/RT alone
cisplatin and radiation therapy
Other Name: platinolRadiation: radiation therapy
Experimental: induction chemo followed by cisplatin/RT
docetaxel, cisplatin and 5-fluorouracil induction chemotherapy followed by surgery and/or cisplatin and radiation therapy
Other Name: platinolDrug: docetaxel
Other Name: taxotereDrug: 5-fluorouracil
Other Name: 5-FUProcedure: surgery
- Compare the overall survival of patients with previously untreated stage III or IV squamous cell carcinoma of the oropharynx treated with induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil followed by radiotherapy and cisplatin versus radiotherapy and cisplatin only.
- Compare the progression-free survival in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life and functional status of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to primary cancer site (base of tongue vs other), nodal extent (N0-1 vs N2-3), radiotherapy plan (conventional [2-D or 3-D conformal radiotherapy] vs intensity modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.
Arm I (induction chemotherapy with or without salvage surgery followed by chemoradiotherapy)
- Induction chemotherapy with or without early salvage surgery: Patients receive docetaxel IV over 1 hour and cisplatin over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 1-3 courses. Patients achieving complete or partial response at the primary site after course 1 receive 2 additional courses of therapy and then proceed to chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration. Patients with stable disease or surgically resectable locoregional disease progression undergo early salvage surgery and then proceed to concurrent chemoradiotherapy within 70 days after surgery. Patients with locoregional unresectable disease progression or patients who refused early salvage surgery proceed directly to concurrent chemoradiotherapy within 3-4 weeks after completion of fluorouracil administration.
- Chemoradiotherapy: Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes concurrently on days 1, 22, and 43* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients undergoing surgery before chemoradiotherapy receive cisplatin on days 1 and 22 only of a 6-week course of radiotherapy.
- Arm II (chemoradiotherapy only): Patients undergo 2-D or 3-D conformal radiotherapy or intensity modulated radiotherapy once daily 5 days a week for 7 weeks and receive cisplatin IV over 30-60 minutes on days 1, 22, and 43 in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after completion of chemoradiotherapy, and then at 12 months after randomization.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: Approximately 398 patients (199 per treatment arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268372
Show 74 Study Locations
|Study Chair:||David J. Adelstein, MD||The Cleveland Clinic|
|Study Director:||Gregory T. Wolf, MD||University of Michigan Cancer Center|
|Study Chair:||P. G. Shankar Giri, MD, MB, BS||Veterans Affairs Medical Center - Houston|