Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced, Resectable Esophageal Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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 damage tumor cells. Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced, resectable esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cisplatin; Docetaxel

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