Back to resultsWeekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Primary Purpose
Esophageal Neoplasms
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasms
Eligibility Criteria
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
Sites / Locations
- CHU de Rouen
Outcomes
Primary Outcome Measures
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Secondary Outcome Measures
toxicity profile
overall survival rate at one and two years
Full Information
NCT ID
NCT00213486
First Posted
September 13, 2005
Last Updated
October 27, 2005
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT00213486
Brief Title
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Official Title
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Rouen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
irinotecan
Primary Outcome Measure Information:
Title
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Secondary Outcome Measure Information:
Title
toxicity profile
Title
overall survival rate at one and two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre MICHEL, MD
Organizational Affiliation
Federation Francophone de Cancerologie Digestive
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
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