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

Primary Purpose

Esophageal Cancer, Squamous Cell

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

pursuit of chemotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer, Squamous Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire
Centre Paul Papin
Centre François Baclesse
Centre Oscar LambretRecruiting
Centre René Gauducheau
Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
Centre Eugène Marquis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A

Arm B

Arm Description

Pursuit of chemotherapy.

Interruption of chemotherapy, best supportive care

Outcomes

Primary Outcome Measures

Estimate the overall survival for patients suffering from Esophageal cancer

Non-progressive disease at and after 6 weeks of treatment until progression

Secondary Outcome Measures

Estimate efficiency in term of overall survival, of pursuing chemotherapy

beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks

Estimate the efficiency in term of progression-free of pursuing chemotherapy

beyond 6 weeks of treatment

Estimate the rate of non progressive patients

after the 6 firsts weeks of treatment

Estimate the overall survival of the whole study population

beyond the inclusion

Measure the toxicity of chemotherapy

during the initial treatment phase compared to the 2 treatment arms after randomization

Estimate the consequences of pursuing chemotherapy

beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits

Full Information

NCT ID

NCT03301454

First Posted

September 12, 2017

Last Updated

August 7, 2018

Sponsor

Centre Oscar Lambret

1. Study Identification

Unique Protocol Identification Number

NCT03301454

Brief Title

Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer

Acronym

E-DIS2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2018 (Anticipated)

Primary Completion Date

February 2022 (Anticipated)

Study Completion Date

February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Oscar Lambret

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Squamous Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Pursuit of chemotherapy.

Arm Title

Arm B

Arm Type

No Intervention

Arm Description

Interruption of chemotherapy, best supportive care

Intervention Type

Drug

Intervention Name(s)

pursuit of chemotherapy

Other Intervention Name(s)

LV5FU2-paclitaxel CT

Intervention Description

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

Primary Outcome Measure Information:

Title

Estimate the overall survival for patients suffering from Esophageal cancer

Description

Non-progressive disease at and after 6 weeks of treatment until progression

Time Frame

From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment

Secondary Outcome Measure Information:

Title

Estimate efficiency in term of overall survival, of pursuing chemotherapy

Description

beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks

Time Frame

From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment

Title

Estimate the efficiency in term of progression-free of pursuing chemotherapy

Description

beyond 6 weeks of treatment

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

Title

Estimate the rate of non progressive patients

Description

after the 6 firsts weeks of treatment

Time Frame

From date of inclusion until the date of the end the 6 firsts weeks of treatment

Title

Estimate the overall survival of the whole study population

Description

beyond the inclusion

Time Frame

From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment

Title

Measure the toxicity of chemotherapy

Description

during the initial treatment phase compared to the 2 treatment arms after randomization

Time Frame

from baseline up to 12 months

Title

Estimate the consequences of pursuing chemotherapy

Description

beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie VANSEYMORTIER

Phone

33320295918

promotion@o-lambret.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farid EL HAJBI, MD

Organizational Affiliation

Centre Oscar Lambret

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Universitaire

City

Amiens

ZIP/Postal Code

80080

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent HAUTEFEUILLE, MD

Phone

+33322088849

heutefeuille.vincent@chu-amiens.fr

First Name & Middle Initial & Last Name & Degree

Vincent HAUTEFEUILLE, MD

Facility Name

Centre Paul Papin

City

Angers

ZIP/Postal Code

49055

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier CAPITAIN, MD

Phone

+33240679900

olivier.capitain@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Olivier CAPITAIN, MD

First Name & Middle Initial & Last Name & Degree

Véronique GUERIN-MEYER, MD

First Name & Middle Initial & Last Name & Degree

Julie VANBOCKSTAEL, MD

Facility Name

Centre François Baclesse

City

Caen

ZIP/Postal Code

14076

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marie-Pierre GALAIS, MD

Phone

+33231455016

mp.galais@baclesse.fr

First Name & Middle Initial & Last Name & Degree

Marie-Pierre GALAIS, MD

First Name & Middle Initial & Last Name & Degree

Françoise POLYCARPE-OSAER, MD

First Name & Middle Initial & Last Name & Degree

Aurélie PARZY, MD

First Name & Middle Initial & Last Name & Degree

Stéphane CORBINAIS, MD

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farid EL HAJBI, MD

Phone

+33320295266

f-elhajbi@o-lambret.fr

First Name & Middle Initial & Last Name & Degree

Frederik LAESTADIUS, MD

First Name & Middle Initial & Last Name & Degree

Diane PANNIER, MD

First Name & Middle Initial & Last Name & Degree

Natacha STERN, MD

First Name & Middle Initial & Last Name & Degree

Nicolas PENEL, PhD

First Name & Middle Initial & Last Name & Degree

Thomas RYCKEWAERT, MD

Facility Name

Centre René Gauducheau

City

Nantes

ZIP/Postal Code

44805

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olivier CAPITAIN, MD

Phone

+33240679900

olivier.capitain@ico.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Hélène SENELLART, MD

First Name & Middle Initial & Last Name & Degree

Sandrine HIRET, MD

First Name & Middle Initial & Last Name & Degree

Olivier CAPITAIN, MD

First Name & Middle Initial & Last Name & Degree

Judith RAIMBOURG, MD

Facility Name

Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

City

Plérin

ZIP/Postal Code

22190

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierre-Luc ETIENNE, MD

Phone

+33296752216

pl.etienne@cario-sante.fr

First Name & Middle Initial & Last Name & Degree

Pierre-Luc ETIENNE, MD

First Name & Middle Initial & Last Name & Degree

Jérôme MARTIN-BABAU, MD

First Name & Middle Initial & Last Name & Degree

Dominique BESSON, MD

First Name & Middle Initial & Last Name & Degree

Anne-Claire HARDY-BESSARD, MD

Facility Name

Centre Eugène Marquis

City

Rennes

ZIP/Postal Code

35042

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julien EDELINE, Pr

Phone

+33299253000

j.edeline@rennes.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Samuel LE SOURD, MD

First Name & Middle Initial & Last Name & Degree

Anais BODERE, MD

First Name & Middle Initial & Last Name & Degree

Julien EDELINE, PhD

First Name & Middle Initial & Last Name & Degree

Claire LARIBLE, MD

First Name & Middle Initial & Last Name & Degree

Fanny LE DU, MD

First Name & Middle Initial & Last Name & Degree

Astrid LIEVRE, MD

First Name & Middle Initial & Last Name & Degree

Marc PRACHT, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer

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