Esophageal Cancer
Conditions
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage III esophageal cancer, stage IV esophageal cancer
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: Primary * Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy. Secondary * Determine the feasibility of this regimen in these patients. * Determine the adverse reactions of this regimen in these patients. * Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen. * Determine overall survival of patients treated with this regimen. * Determine the long-term survival rate in patients treated with this regimen. * Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen. * Determine quality of life and clinical benefit in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Interventions
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.
RADIATIONRadiotherapy
Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.
Sponsors
Swiss Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed esophageal cancer, including the gastroesophageal junction * Squamous cell or adenocarcinoma * Unresectable disease * Meets 1 of the following staging criteria by endoscopic ultrasound: * Cervical (supraclavicular) lesion, meeting 1 of the following stages: * TX, N+ disease * T3-4, NX disease * TX, NX, M1a\* disease * Thoracic (celiac) lesion, meeting 1 of the following stages: * Unresectable T4, NX disease * TX, NX, M1a\* disease * Locally advanced resectable tumors, inoperable due to medical reasons NOTE: \*M1a requires unequivocal abnormality on staging CT scan/endosonography * No T1-2, N0 disease * All tumors encompassable in 1 radiation field * No tumor with esophagotracheal fistula PATIENT CHARACTERISTICS: Performance status * WHO 0-1 Life expectancy * Not specified Hematopoietic * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST ≤ 1.5 times upper limit of normal (ULN) * Bilirubin normal * Alkaline phosphatase ≤ 2.5 times ULN Renal * Creatinine clearance \> 60 mL/min Cardiovascular * No myocardial infarction within the past 3 months * No New York Heart Association class III or IV congestive heart failure * No unstable angina pectoris * No significant arrhythmias * No other severe cardiovascular disease Immunologic * No uncontrolled active infection * No active autoimmune disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study treatment * No definite contraindication to corticosteroids * No uncontrolled diabetes mellitus * No pre-existing peripheral neuropathy \> grade 1 * No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent * No other serious underlying 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 PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Radiotherapy * No prior radiotherapy to the chest Other * More than 30 days since prior experimental treatment in another clinical trial * No other concurrent experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients without local failure measured 6 months after completion of study treatment | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions measured after completion of study treatment | 6 months |
| Successful completion of therapy measured after completion of study treatment | 6 months |
| Dysphagia as measured 6 months after completion of study treatment | 6 months |
Countries
Switzerland
Outcome results
None listed