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

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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