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

Phase 2TerminatedNCT03301454

Centre Oscar Lambret15 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Cancer, Squamous Cell

Interventions

pursuit of chemotherapyDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Hôpital Privé Arras Les Bonnettes

Arras, France

Centre Hospitalier de Boulogne sur mer

Boulogne-sur-Mer, France

Centre François Baclesse

Caen, France

Centre Oscar Lambret

Lille, France

Centre René Gauducheau

Outcomes

Primary Outcomes

Estimate the overall survival for patients suffering from Esophageal cancer

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 Outcomes

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

Time frame: 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

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

Estimate the rate of non progressive patients

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

Estimate the overall survival of the whole study population

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

Measure the toxicity of chemotherapy

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

Time frame: from baseline up to 12 months

Estimate the consequences of pursuing chemotherapy

Data from ClinicalTrials.gov

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