Trial Information
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at
days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was
delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.
Inclusion Criteria:
- esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
- performance status
- caloric intake>1500 KCal/d
- serum albumin >32 gr/l
- serum creatinine<120 microgr/l
- total serum bilirubin < 1.5 mg/ml
- no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm
- no prior history of malignancy other than cell carcinoma of the skin, in siyu
cervical carcinoma, or head and neck carcinoma with complete response since 3 years
- written informed consent
Exclusion Criteria:
- Gilbert's syndrome
- cardiac disease as NYHA class 3 or 4
- myocardial infarction within the previous 6 months
- metastatic disease
- histologically proved invasion of tracheobronchial tree
- metastatic disease
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Principal Investigator
Pierre MICHEL, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
FFCD
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2001/141/HP
NCT ID:
NCT00213486
Start Date:
June 2002
Completion Date:
December 2004
Related Keywords:
- Esophageal Neoplasms
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms