Clinical trial · Interventional
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.
A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Esophagus | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Supportive Care | Other | — | UNRESOLVED |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| FU-CDDP | Drug | — | UNRESOLVED |
| LV5FU2-CDDP | Drug | — | UNRESOLVED |
| TPF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy plus best supportive care
- description
- Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF
- interventionNames
- Drug: FU-CDDP
- Drug: LV5FU2-CDDP
- Drug: FOLFOX
- Drug: TPF
- type
- ACTIVE_COMPARATOR
- label
- Best supportive care
- description
- Best supportive care with follow up every 6 weeks
- interventionNames
- Other: Best Supportive Care
Primary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with an histologically proven epidermoid cancer of the oesophagus * Patients with metastatic disease that can be measured or evaluated according to the RECIST criteria, and located outside of previously irradiated fields * Patients who may or may not have undergone radiochemotherapy * Patients who have not received chemotherapy for metastatic disease * ≥ 18 ans * Performance Status (ECOG) ≤ 2 * People who are covered by private or state health insurance * Informed consent signed by the patient Exclusion Criteria: * Other evolutive malignant tumor * Infection with HIV-1, HIV-2 or chronic hepatitis B or C * Cerebral metastasis or known meningeal tumor * Any unstable chronic diseases that could risk the safety or the compliance of te patient * Women who are pregnant or breastfeeding. Women must not breastfeed for at least 6 months after administration of Bevacizumab * Patients unable to undergo the follow-up of the trial for geographical, social or psychological reasons For the randomized part Inclusion criteria : * Non-progressive disease after the 6 first weeks of chemotherapy * Performance Status (ECOG) ≤ 2
References
Publications (1)
- DERIVEDKotecki N, Hiret S, Etienne PL, Penel N, Tresch E, Francois E, Galais MP, Ben Abdelghani M, Michel P, Dahan L, Ghiringelli F, Bedenne L, Samalin E, Piessen G, Bennouna J, Peugniez C, El Hajbi F, Clisant S, Kramar A, Mariette C, Adenis A. First-Line Chemotherapy for Metastatic Esophageal Squamous Cell Carcinoma: Clinico-Biological Predictors of Disease Control. Oncology. 2016;90(2):88-96. doi: 10.1159/000442947. Epub 2016 Jan 20. PMID 26784946