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
Procedure: conventional surgery
Radiation: radiation therapy
|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|