Status:
COMPLETED
Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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. Radiati...
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 * Dete...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00238407
Start Date
March 1 2004
End Date
August 1 2010
Last Update
June 5 2012
Active Locations (10)
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1
Hirslanden Klinik Aarau
Aarau, Switzerland, CH-5001
2
Saint Claraspital AG
Basel, Switzerland, CH-4016
3
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
4
Inselspital Bern
Bern, Switzerland, CH-3010