Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

Phase 2

Completed

• Conditions: Esophageal Neoplasms

• Registration Number: NCT00213486
• Lead Sponsor: University Hospital, Rouen

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 which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.

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 with 50Gy in 25 fractions/5 weeks.

Study Timeline

• Study Start: 2002-06
• Study Completion: 2004-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2005-10-27
• Last Update Posted: 2005-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan

Secondary Outcome Measures

Name	Time	Method
toxicity profile
overall survival rate at one and two years

Trial Locations

Locations (1)

CHU de Rouen; 🇫🇷 Rouen, France