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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
cisplatin and docetaxel chemo- and radiochemotherapy
Kantonspital Aarau
Aarau, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Inselspital Bern
Bern, Switzerland
Spitaeler Chur AG
Chur, Switzerland
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Ospedale Civico
Lugano, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
City Hospital Triemli
Zurich, Switzerland
Feasibility of successful study therapy completion and survival after surgery
Time frame: 30 days
Adverse events
Time frame: 30 days
Overall survival
Time frame: Life-long
Feasibility in Switzerland after surgery
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.