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
  Purpose

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.


Condition Intervention Phase
Esophageal Neoplasms
Drug: irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

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

Estimated Enrollment: 43
Study Start Date: June 2002
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213486

Locations
France
CHU de Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Pierre MICHEL, MD FFCD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213486     History of Changes
Other Study ID Numbers: 2001/141/HP
Study First Received: September 13, 2005
Last Updated: October 27, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Cisplatin
Camptothecin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 22, 2014