Status:
COMPLETED
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer
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, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to d...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00072033
Start Date
March 1 2003
End Date
May 1 2010
Last Update
June 5 2012
Active Locations (9)
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1
Kantonspital Aarau
Aarau, Switzerland, CH-5001
2
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
3
Inselspital Bern
Bern, Switzerland, CH-3010
4
Spitaeler Chur AG
Chur, Switzerland, CH-7000