NCT00213486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 28, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

October 27, 2005

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • toxicity profile

  • overall survival rate at one and two years

Interventions

irinotecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Pierre MICHEL, MD

    Federation Francophone de Cancerologie Digestive

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2002

Study Completion

December 1, 2004

Last Updated

October 28, 2005

Record last verified: 2005-09

Locations

FR(1)