Status:
UNKNOWN
Study of the Interest of Pursuing or Not the Chemotherapy for Patients With Metastatic Esophageal Cancer
Lead Sponsor:
Centre Oscar Lambret
Conditions:
Esophageal Cancer, Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ph...
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) e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03301454
Start Date
September 1 2018
End Date
February 1 2022
Last Update
August 8 2018
Active Locations (7)
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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