Clinical trial · Interventional
Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This decision was taken on June 20 2022 due to low recruitment over the past 4 years.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer, Squamous Cell | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pursuit of chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Pursuit of chemotherapy.
- interventionNames
- Drug: pursuit of chemotherapy
- type
- NO_INTERVENTION
- label
- Arm B
- description
- Interruption of chemotherapy, best supportive care
Primary outcomes (1)
- measure
- 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
- description
- Non-progressive disease at and after 6 weeks of treatment until progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available