Suspended

Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

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What is being tested

Data Collection

Who is being recruted

Digestive System Diseases+6

+ Digestive System Neoplasms

+ Esophageal Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy. Secondary * Determine the clinical benefit in patients treated with this regimen. * Determine the tolerability of this regimen in these patients. * Determine local relapse-free survival of patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.

Official TitlePhase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus 
NCT00075738
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed esophageal cancer * Metastatic disease * At least 1 unidimensionally measurable metastatic lesion * At least 10 mm by spiral scanner OR 20 mm by sequential scanner * Outside the field of prior radiotherapy * No known symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times normal * Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present) * SGOT and SGPT ≤ 3 times normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No uncontrolled angina Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No other illness or medical condition that would preclude study participation * No psychological, social, familial, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior fluorouracil and/or cisplatin * No other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 6 weeks since prior radiotherapy Surgery * More than 4 weeks since prior surgery Other * No concurrent participation in another clinical study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

Clinique La Casamance

Abugne, FranceSee the location
Suspended

Hopital Saint Andre

Bordeaux, France
Suspended

Hopital Drevon

Dijon, France
Suspended

Centre Jean Bernard

Le Mans, France
Suspended15 Study Centers