Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
- Conditions
- Esophageal Cancer, Squamous Cell
- Interventions
- Drug: pursuit of chemotherapy
- Registration Number
- NCT03301454
- Lead Sponsor
- Centre Oscar Lambret
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A pursuit of chemotherapy Pursuit of chemotherapy.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
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
Trial Locations
- Locations (7)
Centre René Gauducheau
🇫🇷Nantes, France
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Universitaire
🇫🇷Amiens, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre François Baclesse
🇫🇷Caen, France
Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie
🇫🇷Plérin, France
Centre Eugène Marquis
🇫🇷Rennes, France