Esophageal Cancer, Squamous Cell
Conditions
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 * 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
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: * Arm A : pursuit of chemotherapy and best supportive care * Arm B : interruption of chemotherapy and best supportive care
Interventions
DRUGpursuit 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
Sponsors
Centre Oscar Lambret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFarid EL HAJBI, MD
Centre Oscar Lambret
Outcome results
None listed