Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Docetaxel and Cisplatin
- Conditions
- Esophageal Cancer
- Sponsor
- Swiss Group for Clinical Cancer Research
- Enrollment
- 21
- Locations
- 10
- Primary Endpoint
- Proportion of patients without local failure measured 6 months after completion of study treatment
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Primary * Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy. Secondary * Determine the feasibility of this regimen in these patients. * Determine the adverse reactions of this regimen in these patients. * Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen. * Determine overall survival of patients treated with this regimen. * Determine the long-term survival rate in patients treated with this regimen. * Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen. * Determine quality of life and clinical benefit in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Intervention: Docetaxel and Cisplatin
Arm I
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Proportion of patients without local failure measured 6 months after completion of study treatment
Time Frame: 6 months
Secondary Outcomes
- Adverse reactions measured after completion of study treatment(6 months)
- Successful completion of therapy measured after completion of study treatment(6 months)
- Dysphagia as measured 6 months after completion of study treatment(6 months)