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Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

NCT01248299 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-05-16

No results posted yet for this study

Summary

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

Conditions

  • Squamous Cell Carcinoma of Esophagus

Interventions

DRUG

FU-CDDP

every 21 days: * Fluoro-uracil \[800 mg/m2, day 1 to day 5\] * CisPlatin \[75 mg/m2, day 1 or day 2\]

DRUG

LV5FU2-CDDP

every 14 days: * Elvorin \[200 mg/m2, 2h IV, day 1 and day 2\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, 22h continous infusion, day 1 and day 2\] * CisPlatin \[50 mg/m2, day 2\]

DRUG

FOLFOX

every 14 days: * Oxaliplatin \[85 mg/m2 by 2h infusion, day 1\] * Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\] * Fluoro-uracil \[600 mg/m2, by 22h continous infusion, day 1 and day 2\] * Elvorin \[500 mg/m2, day 1 and day 2\]

DRUG

TPF

every 21 days: * Docetaxel \[30 mg/m2, day 1 and day 8\] * CisPlatin \[60 mg/m2, day 1\] * Fluoro-uracil \[200 mg/m2/day by continous infusion\] Or every 21 days: * Docetaxel \[50 mg/m2, day 1\] * CisPlatine \[70 mg/m2, day 1\] * Fluoro-uracile \[700 mg/m2 /day, day 1 to day 5\]

OTHER

Best Supportive Care

See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Antoine ADENIS, MD, PhD · Centre Oscar Lambret

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-01-31
Completion
2017-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01248299 on ClinicalTrials.gov