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

Sponsor
University Hospital, Rouen
Study ID
NCT00213486
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 15, 2003
Status verified
Feb 2026
Primary completion
Jun 23, 2006
Completion
Jun 23, 2006

Study Design

Enrollment
43 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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

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