E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from squamous-cell type esophageal cancer histologically proved and with 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 fluoropyrimidin with a platinium salt.
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E.1.1.1 | Medical condition in easily understood language |
Patients suffering from a metastatic esophageal squamous cell cancer and already received a chemotherapy treatment for a metastatic disease. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Estimate the overall survival for patients suffering from non-progressive Esophageal cancer at and after 6 weeks of treatment until progression
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E.2.2 | Secondary objectives of the trial |
Estimate efficiency in term of overall survival, of pursuing chemotherapy 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 beyond 6 weeks of treatment
Measure the toxicity of chemotherapy during the initial treatment phase compared to the 2 treatment arms after randomization
Estimate the conséquences of pursuing chemotherapy beyond 6 weeks of treatment in term of time until degradation of life quality and in term of overall benefits |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 fluoropyrimidin with a platinium salt
•Man or woman over 18 years old
•ECOG performance status ≤ 2
•PNN ≥ 1500/ mm3
•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
For randomization:
•ECOG perfromance status ≤ 2
•Able to pursuit the LV5FU2-paclitaxel chemotherapy
•Non-progressive disease after the initial phase (first tumor exam at week 6)
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E.4 | Principal exclusion criteria |
•Patients who received more than one line of chemotherapy for a metastatic disease
•Presence of other evolutive tumors
•Cerebral metastasis or known brain tumor
•Severe liver failure
•Pernicious anemia or other anemia due to vitamin B12 deficiency
•Hypersensibility to an active substance or other excipient of experimental drugs
•Every unstable chronicle diseases that can affect patient confidence or security
•Patient with a known dihydropyrimidine dehydrogenase deficiency
•Pregnant or breastfeeding women
•Unable to comply with the medical monitoring for geographic, social or mental issues
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival from randomization, defined as time between randomization and death from any cause ; patients who remain alive, are censured at the date of latest news. More specifically, we will be interested in the survival after 30 weeks following the randomization (which corresponds to about 8 months after the beginning of the treatment). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From date of randomization until the date of death from any cause, up to 8 months after the beginning of the treatment. |
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E.5.2 | Secondary end point(s) |
Efficiency :
Progression-free survival, defined as the time between randomization and the progression or death from any cause ; patients who are still alive and did not show sign of progression are censured at the date of latest news.
Tolerability :
Adverse events are evaluated and graded according to the NCI-CTCAE v4.0 scale. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
interruption of the treatment |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |