Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable, Locally Advanced Esophageal Cancer, A Multicenter Phase II Trial

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: Docetaxel and Cisplatin
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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

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 I<br>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. | Drug: Docetaxel and Cisplatin<br>* Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71.<br>Radiation: Radiotherapy<br>* Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without local failure measured 6 months after completion of study treatment |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

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