Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer (E-DIS2)

August 7, 2018 updated by: Centre Oscar Lambret

Phase II Randomized Study Measuring the Interest of Pursuing or Not the CT for Non-progressive Patients With Metastatic Esophageal Squamous-cell Cancer After 6 Weeks of LV5FU2-paclitaxel Given After a 1st Line Fluoropyrimidine/Pt Salt CT

Phase II study, randomized, open-label, multicentric, willing to establish the benefit of pursuing chemotherapy beyond 6 weeks for non progressive patients. The study will proceed in two successive phases :

  • non randomized phase in which all patients will undergo chemotherapy
  • second phase in which only non progressive patients are going to be randomized ("discontinuation design"). Patients that will show progression in their disease during the first 6 weeks will be released of the study

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.

Randomized phase:

  • Arm A : pursuit of chemotherapy and best supportive care
  • Arm B : interruption of chemotherapy and best supportive care

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80080
        • Not yet recruiting
        • Centre Hospitalier Universitaire
        • Principal Investigator:
          • Vincent HAUTEFEUILLE, MD
        • Contact:
      • Angers, France, 49055
        • Not yet recruiting
        • Centre Paul Papin
        • Sub-Investigator:
          • Julie VANBOCKSTAEL, MD
        • Contact:
        • Principal Investigator:
          • Olivier CAPITAIN, MD
        • Sub-Investigator:
          • Véronique GUERIN-MEYER, MD
      • Caen, France, 14076
        • Not yet recruiting
        • Centre Francois Baclesse
        • Contact:
        • Principal Investigator:
          • Marie-Pierre GALAIS, MD
        • Sub-Investigator:
          • Françoise POLYCARPE-OSAER, MD
        • Sub-Investigator:
          • Aurélie PARZY, MD
        • Sub-Investigator:
          • Stéphane CORBINAIS, MD
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
        • Sub-Investigator:
          • Frederik LAESTADIUS, MD
        • Sub-Investigator:
          • Nicolas PENEL, PhD
      • Nantes, France, 44805
        • Not yet recruiting
        • Centre Rene Gauducheau
        • Contact:
        • Principal Investigator:
          • Olivier CAPITAIN, MD
        • Sub-Investigator:
          • Hélène SENELLART, MD
      • Plérin, France, 22190
        • Not yet recruiting
        • Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
        • Principal Investigator:
          • Pierre-Luc ETIENNE, MD
        • Contact:
        • Sub-Investigator:
          • Jérôme MARTIN-BABAU, MD
        • Sub-Investigator:
          • Dominique BESSON, MD
        • Sub-Investigator:
          • Anne-Claire HARDY-BESSARD, MD
      • Rennes, France, 35042
        • Not yet recruiting
        • Centre Eugène Marquis
        • Principal Investigator:
          • Samuel Le Sourd, MD
        • Contact:
        • Sub-Investigator:
          • Anais BODERE, MD
        • Sub-Investigator:
          • Julien EDELINE, PhD
        • Sub-Investigator:
          • Claire LARIBLE, MD
        • Sub-Investigator:
          • Fanny LE DU, MD
        • Sub-Investigator:
          • Astrid LIEVRE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from squamous-cell type esophageal cancer histologically proved
  • Metastatic disease measurable according to RECIST criteria. Patients with metachronous metastasis and who have been treated with surgery (+/- radio chemotherapy concurrent or adjuvant chemotherapy) or exclusive radio chemotherapy, are eligible
  • Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt
  • Man or woman over 18 years old
  • ECOG performance status ≤ 2
  • Adequate haematological, renal and hepatic functions : PNN ≥ 1500/ mm3; platelets ≥ 100 000/ mm3; Haemoglobin ≥ 9.0 g/dL; ALT and AST ≤ 2.5 ULN (≤ 5.0 in case of liver metastases); Total bilirubin ≤ 1.5 X ULN; Serum creatinine ≤ 1.5 ULN
  • Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration
  • Affiliation to the National Social Security System
  • With informed and signed consent

Inclusion Criteria for randomization:

  • ECOG performance status ≤ 2
  • Able to pursuit the LV5FU2-paclitaxel chemotherapy
  • Non-progressive disease after the initial phase (first tumor exam at week 6)

Exclusion Criteria:

  • Patients who received more than one line of chemotherapy for a metastatic disease
  • Presence of other evolutive tumors
  • Cerebral metastasis or other known brain tumors
  • Severe liver failure
  • Pernicious anemia or other anemia due to vitamin B12 defficiency
  • Hypersensibility to an active substance or any other excipients of experimental drugs
  • Every unstable chronicle diseases that can affect patient confidence or security
  • Clinically significant active cardiac disease or myocardial infarction in the 6 previous months
  • Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin
  • Live attenuated vaccine within the 3 previous months
  • Pregnant or breastfeeding women
  • Unable to comply with the medical monitoring for geographic, social or mental issues
  • Patient Under guardianship or tutorship

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Pursuit of chemotherapy.
Drug: pursuit of chemotherapy
Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
Other Names:
  • LV5FU2-paclitaxel CT
No Intervention: Arm B
Interruption of chemotherapy, best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate the overall survival for patients suffering from Esophageal cancer
Time Frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Non-progressive disease at and after 6 weeks of treatment until progression
From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimate efficiency in term of overall survival, of pursuing chemotherapy
Time Frame: From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the efficiency in term of progression-free of pursuing chemotherapy
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment
From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
Estimate the rate of non progressive patients
Time Frame: From date of inclusion until the date of the end the 6 firsts weeks of treatment
after the 6 firsts weeks of treatment
From date of inclusion until the date of the end the 6 firsts weeks of treatment
Estimate the overall survival of the whole study population
Time Frame: From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
beyond the inclusion
From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment
Measure the toxicity of chemotherapy
Time Frame: from baseline up to 12 months
during the initial treatment phase compared to the 2 treatment arms after randomization
from baseline up to 12 months
Estimate the consequences of pursuing chemotherapy
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment
beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: Farid EL HAJBI, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

February 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

October 3, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-DIS2-1705
  • 2017-003660-13 (EudraCT Number)
  • 170757A-12 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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