E-DIS2: Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
Study Details
Study Description
Brief 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
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Initial phase: this part of the trial consist of 3 cycles of LV5FU2 (Bolus 5-FU 400mg/m² - 5-FU continuously during 46h: 3000 mg/m², calcium levofolinate 200 mg/m²) - paclitaxel (100 mg/m² at day 1) every 14 days. After 6 weeks,the phase will end with a check-up (clinical exam, tumor evaluation and biological test). Then, if the disease is non-progressive, the patient will proceed to the randomized phase.
Randomized phase:
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Arm A : pursuit of chemotherapy and best supportive care
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Arm B : interruption of chemotherapy and best supportive care
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A Pursuit of chemotherapy. |
Drug: pursuit of chemotherapy
Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
Other Names:
|
| No Intervention: Arm B Interruption of chemotherapy, best supportive care |
Outcome Measures
Primary Outcome Measures
- Estimate the overall survival for patients suffering from Esophageal cancer [From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment]
Non-progressive disease at and after 6 weeks of treatment until progression
Secondary Outcome Measures
- Estimate efficiency in term of overall survival, of pursuing chemotherapy [From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment]
beyond 6 weeks of treatment compared to a group that interrupted the treatment at 6 weeks
- Estimate the efficiency in term of progression-free of pursuing chemotherapy [From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment]
beyond 6 weeks of treatment
- Estimate the rate of non progressive patients [From date of inclusion until the date of the end the 6 firsts weeks of treatment]
after the 6 firsts weeks of treatment
- Estimate the overall survival of the whole study population [From date of inclusion until the date of death from any cause, up to 8 months after the beginning of the treatment]
beyond the inclusion
- Measure the toxicity of chemotherapy [from baseline up to 12 months]
during the initial treatment phase compared to the 2 treatment arms after randomization
- Estimate the consequences of pursuing chemotherapy [From date of randomization until the date of first documented progression or date of death from any cause, up to 8 months after the beginning of the treatment]
beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients suffering from squamous-cell type esophageal cancer histologically proved
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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
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Patients who show progress under chemotherapy that associates a fluoropyrimidine with a platinum salt
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Man or woman over 18 years old
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ECOG performance status ≤ 2
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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
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Efficient contraceptive method for both gender (if applicable), during the whole treatment period and the 6 months following the last treatment administration
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Affiliation to the National Social Security System
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With informed and signed consent
Inclusion Criteria for randomization:
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ECOG performance status ≤ 2
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Able to pursuit the LV5FU2-paclitaxel chemotherapy
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Non-progressive disease after the initial phase (first tumor exam at week 6)
Exclusion Criteria:
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Patients who received more than one line of chemotherapy for a metastatic disease
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Presence of other evolutive tumors
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Cerebral metastasis or other known brain tumors
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Severe liver failure
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Pernicious anemia or other anemia due to vitamin B12 defficiency
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Hypersensibility to an active substance or any other excipients of experimental drugs
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Every unstable chronicle diseases that can affect patient confidence or security
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Clinically significant active cardiac disease or myocardial infarction in the 6 previous months
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Patients with a known dihydropyrimidine dehydrogenase (DPD) deficiency
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Concomitant treatment with : sorivudin or analogs; prophylactic phenytoin
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Live attenuated vaccine within the 3 previous months
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Pregnant or breastfeeding women
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Unable to comply with the medical monitoring for geographic, social or mental issues
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Patient Under guardianship or tutorship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire | Amiens | France | 80080 | |
| 2 | Centre Paul Papin | Angers | France | 49055 | |
| 3 | Centre François Baclesse | Caen | France | 14076 | |
| 4 | Centre Oscar Lambret | Lille | France | 59020 | |
| 5 | Centre René Gauducheau | Nantes | France | 44805 | |
| 6 | Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie | Plérin | France | 22190 | |
| 7 | Centre Eugène Marquis | Rennes | France | 35042 |
Sponsors and Collaborators
- Centre Oscar Lambret
Investigators
- Principal Investigator: Farid EL HAJBI, MD, Centre Oscar Lambret
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E-DIS2-1705
- 2017-003660-13
- 170757A-12