Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
N/A
74 Years
Both
Esophageal Cancer
Trial Information
Randomized Study of Pre-Operative Radio-Chemotherapy Versus Surgery Alone in Thoracic Esophageal Cancer Deemed to be Resectable
OBJECTIVES:
- Compare the overall survival of patients with resectable thoracic esophageal cancer
treated with neoadjuvant radio-chemotherapy and surgery versus surgery alone.
- Compare the disease-free survival of patients treated with these regimens.
- Compare the surgical mortality and morbidity of patients treated with these regimens.
- Compare the resectability of patients treated with these regimens.
- Determine the validation of new prognostic factors for survival of these patients
and/or the efficacy of this neoadjuvant treatment.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to histology (epidermoid carcinoma vs adenocarcinoma vs undifferentiated
carcinoma), stage (I vs IIA vs IIB), tumor location (above the carina vs below the carina),
and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiotherapy daily 5 days a week for 5 weeks. Patients receive
fluorouracil IV continuously on days 1-4 and 29-32 and cisplatin IV on days 1 or 2 and
29 or 30 (or a lower dose on days 1-5 and 29-33). Within 4-8 weeks after completion of
radio-chemotherapy, patients undergo surgical resection.
- Arm II: Patients undergo surgical resection. Patients are followed every 4 months for 2
years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 380 patients (190 per treatment arm) will be accrued for this
study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of stage I or II thoracic esophageal cancer
- Tumor no greater than 3 cm with no invasion of mediastinal structures with or
without extension to the lymph nodes (T1-2, N0-1, M0) OR
- Tumor greater than 3 cm with no invasion of mediastinal structures and no
adenopathy greater than 1 cm (T3, N0, M0)
- Epidermoid carcinoma or adenocarcinoma
- Previously untreated
- Deemed resectable with curative intent
- No carcinoma in situ
- No small cell anaplastic carcinoma (i.e., chromogranin negative)
- No small cell neuroendocrine carcinoma (i.e., chromogranin positive)
- No multifocal esophageal carcinoma (i.e., 2 or more distinct lesions 5 or more cm
apart)
- No involvement of the pharyngoesophageal junction and the first 4 cm of the esophagus
(i.e., where the proximal edge of the tumor is less than 19 cm from the dental arch)
- No evidence of extension to the tracheobronchial tree at endoscopy, ultrasound, or CT
scan (simple compression allowed)
- No signs of mediastinal involvement on CT scan
- No palpable subclavicular lymph nodes or involvement after cytology needle aspiration
- No lymph nodes from the origin of the celiac greater than 1 cm on CT scan
- Perigastric lymph nodes far from the celiac trunk and deemed resectable allowed
unless tumor is more than 30 mm on CT scan
PATIENT CHARACTERISTICS:
Age
- Under 75
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- SGOT/SGPT ratio no greater than 1
- Albumin at least 35 g/L
- Total protein greater than 80%
- No liver cirrhosis with previous failure
- No ascites
- No jaundice
- No rupture of varicose esophageal veins
- No presence of varicose esophageal veins
Renal
- Creatinine no greater than 1.25 times normal
Cardiovascular
- Arterial O_2 greater than 60 mm Hg
- Arterial CO_2 no greater than 45 mm Hg
- No myocardial infarction within the past 6 months
- No progressive coronary artery disease grade 2 or greater
- No recent left ventricular failure
- No arterial disease stage II-IV
Pulmonary
- FEV_1 greater than 1 L/sec
Other
- Able to receive either study treatment
- No recurrent paralysis
- No weight loss greater than 10% from baseline
- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in
situ of the cervix
- Not pregnant
- Fertile patients must use effective contraception during and for 3 months after
completion of chemotherapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
J. P. Triboulet
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Hospitalier Regional et Universitaire de Lille
Authority:
United States: Federal Government
Study ID:
CDR0000257600
NCT ID:
NCT00047112
Start Date:
May 2002
Completion Date:
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage I esophageal cancer
- stage II esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
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