Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Cisplatin and Docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus, including the gastroesophageal junction (Siewert type I) Locally advanced disease that is technically operable with curative intent (R0) T3, N0 OR T1-3, N+ OR T4, NX No T1-2, N0 No inoperable T4 (unequivocal organ involvement) No distant metastasis, including M1a lymph node status Lymph nodes suspicious of M1a status by CT scan, PET scan, or ultrasound must be verified by fine-needle aspiration cytology No carcinoma of the cervical esophagus Obstructive tumors allowed PATIENT CHARACTERISTICS: Age 18 to 70 Performance status WHO 0-1 Life expectancy Not specified Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic AST no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance greater than 60 mL/min Cardiovascular No New York Heart Association class III or IV congestive heart failure No unstable angina pectoris No myocardial infarction within the past 3 months No significant arrhythmias No other severe or uncontrolled cardiovascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 12 months after study treatment No definite contraindications to corticosteroids as premedication No geographic situation that would preclude proper staging and follow-up No active uncontrolled infection No preexisting peripheral neuropathy greater than grade 1 No uncontrolled diabetes mellitus No active autoimmune disease No other serious medical condition that would preclude study participation No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures that would preclude comprehension and ability to provide informed consent and complete quality of life questionnaires PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the chest Surgery Not specified Other More than 30 days since prior treatment on another clinical trial No other concurrent experimental drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Docetaxel and Cisplatin chemo- and radiochemotherapy followed by surgery | Drug: Cisplatin and Docetaxel<br>* cisplatin and docetaxel chemo- and radiochemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of successful study therapy completion and survival after surgery |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 30 days | 
| Overall survival |  | Life-long | 
| Feasibility in Switzerland after surgery |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II esophageal cancer, stage III esophageal cancer, adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus