TerminatedPhase 2

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

Stopped: This decision was taken on June 20 2022 due to low recruitment over the past 4 years.

France15 participantsStarted 2018-08-20

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Hypers…

What they're measuring

Estimate the overall survival for patients suffering from Esophageal cancer

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

Trial details

NCT IDNCT03301454

SponsorCentre Oscar Lambret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-05