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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213486
First received: September 13, 2005
Last updated: October 27, 2005
Last verified: September 2005
History of Changes

September 13, 2005
October 27, 2005
June 2002
Not Provided
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
Same as current
Complete list of historical versions of study NCT00213486 on ClinicalTrials.gov Archive Site
  • toxicity profile
  • overall survival rate at one and two years
Same as current
Not Provided
Not Provided
 
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Neoplasms
Drug: irinotecan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00213486
2001/141/HP
Not Provided
Not Provided
University Hospital, Rouen
Not Provided
Principal Investigator: Pierre MICHEL, MD FFCD
University Hospital, Rouen
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP