Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With Locally Advanced Esophageal Cancer - A Multicenter Phase II Trial
Cisplatin and Docetaxel
Digestive System Diseases+6
+ Digestive System Neoplasms
+ Esophageal Diseases
Treatment Study
Summary
Study start date: March 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.66 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Universitaetsspital-Basel
Basel, SwitzerlandInselspital Bern
Bern, SwitzerlandSpitaeler Chur AG
Chur, Switzerland