Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
- Registration Number
- NCT00072033
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A Cisplatin and Docetaxel Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery
- Primary Outcome Measures
Name Time Method Feasibility of successful study therapy completion and survival after surgery 30 days
- Secondary Outcome Measures
Name Time Method Adverse events 30 days Overall survival Life-long Feasibility in Switzerland after surgery 30 days
Trial Locations
- Locations (9)
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨ðŸ‡Lausanne, Switzerland
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Spitaeler Chur AG
🇨ðŸ‡Chur, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Ospedale Civico
🇨ðŸ‡Lugano, Switzerland
City Hospital Triemli
🇨ðŸ‡Zurich, Switzerland
Universitaetsspital-Basel
🇨ðŸ‡Basel, Switzerland