Status:
COMPLETED
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Lead Sponsor:
University Hospital, Rouen
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen wh...
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
- performance status \<OR=2 (ECOG)
- 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
- 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
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00213486
Start Date
June 1 2002
End Date
December 1 2004
Last Update
October 28 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Rouen
Rouen, France, 76031