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

NCT03301454 | Terminated Phase 2

• 4 other identifiers: E-DIS2-1006API-16-322017-003660-13170757A-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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

Conditions

Esophageal Cancer, Squamous Cell

Outcome Measures

Primary Outcomes (1)

• Estimate the overall survival for patients suffering from Esophageal cancer

  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 Outcomes (6)

• Estimate efficiency in term of overall survival, of pursuing chemotherapy

  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

  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

  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

  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

  from baseline up to 12 months

Study Arms (2)

Arm A

EXPERIMENTAL

Pursuit of chemotherapy.

Drug: pursuit of chemotherapy

Arm B

NO INTERVENTION

Interruption of chemotherapy, best supportive care

Interventions

pursuit of chemotherapy DRUG

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

Also known as: LV5FU2-paclitaxel CT

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Oscar Lambret: lead

Study Sites (5)

Hôpital Privé Arras Les Bonnettes

Arras, 62000, France

Location

Centre Hospitalier de Boulogne sur mer

Boulogne-sur-Mer, 62200, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre René Gauducheau

Nantes, 44805, France

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Farid EL HAJBI, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 4, 2017
• Study Start: August 20, 2018
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)