Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
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 chemotherapy with radiation therapy following surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
|Head and Neck Cancer||Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck|
- Patient tolerance of the treatment regimen [ Time Frame: From registration to end of treatment ]
- Frequency of grade 5 and acute non-hematologic grade 4 toxicity [ Time Frame: From start of induction chemotherapy to 90 days after start of radiation therapy ]
- Frequency of other acute and late toxicity [ Time Frame: From start of induction chemotherapy to last follow-up ]
- Local-regional control [ Time Frame: From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ]
- Disease-free survival [ Time Frame: From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ]
- Overall survival [ Time Frame: From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. ]
|Study Start Date:||March 2001|
|Study Completion Date:||June 2010|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
Experimental: Surgery, chemotherapy and radiation therapy
Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
|Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy|
- Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the acute and chronic toxicity of this regimen in these patients.
- Determine the patterns of failure in patients treated with this regimen.
OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011999
Show 234 Study Locations
|Study Chair:||Randal S. Weber, MD||Abramson Cancer Center of the University of Pennsylvania|