Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial|
- Feasibility of successful study therapy completion and survival after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Life-long ] [ Designated as safety issue: No ]
- Feasibility in Switzerland after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
Active Comparator: Arm A
Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
Drug: Cisplatin and Docetaxel
cisplatin and docetaxel chemo- and radiochemotherapy
- Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery, in terms of pathological response rate, in patients with locally advanced, resectable esophageal cancer.
- Determine the feasibility of this regimen, in terms of successful completion of therapy and survival at 30 days postoperatively, in these patients.
- Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results.
- Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefit of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22.
- Chemoradiotherapy: Beginning 21 days after the last dose of neoadjuvant chemotherapy, patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks.
- Surgery: Patients undergo surgery 3-8 weeks after the final administration of radiotherapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, day 22 of chemotherapy, day 1 of chemoradiotherapy, before surgery, and then every 3 months for 1 year.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 22-66 patients will be accrued for this study.
|Aarau, Switzerland, CH-5001|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Spitaeler Chur AG|
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Lugano, Switzerland, CH-6900|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Study Chair:||Thomas Ruhstaller, MD||Kantonsspital St. Gallen|