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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021439-16 | Other Identifier | IDRCB Number - AFSSAPS |
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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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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.
As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy plus best supportive care | Experimental | Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF |
|
| Best supportive care | Active Comparator | Best supportive care with follow up every 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FU-CDDP | Drug | every 21 days:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Between the date of randomisation and the date of death |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Between the date of randomisation and the date of progression | |
| Tolerance | According to the NCI-CTCAE V4.0 grading scale | At each visit : every 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
For the randomized part
Inclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Antoine ADENIS, MD, PhD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | 29200 | France | |||
| Centre François BACLESSE |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26784946 | Derived | Kotecki 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 12, 2026 | |
| Reset | Mar 31, 2026 |
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| LV5FU2-CDDP | Drug | every 14 days:
|
|
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| FOLFOX | Drug | every 14 days:
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|
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| TPF | Drug | every 21 days:
Or every 21 days:
|
|
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| Best Supportive Care | Other | See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ... |
|
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| Quality of life by QLQ-C30 | EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module EQ-5D questionnaire | Every 6 weeks |
| Cost analysis | Data collected :
| Every 6 weeks |
| Caen |
| 14076 |
| France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| CHU Dijon | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| CHU Lille | Lille | 59035 | France |
| CHU La Timone | Marseille | 13385 | France |
| Centre Val d'Aurelle | Montpellier | 34298 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Clinique de la Theuillerie | Ris-Orangis | 91130 | France |
| CHU Rouen | Rouen | 76031 | France |
| Clinique de l'Armoricaine | Saint-Brieuc | 22000 | France |
| Centre René Gauducheau | Saint-Herblain | 44805 | France |
| Centre Paul Strauss | Strasbourg | 67000 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| Centre Hospitalier Intercommunal | Villeneuve-Saint-Georges | 94190 | France |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 12, 2026 | Mar 31, 2026 |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C112530 | 5-FU-CDDP protocol |
| C410216 | Folfox protocol |
| D018529 | Nutritional Support |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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