Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: All initial characteristics will be described in the overall population and by treatment arm. Evaluation criteria related to efficacy and safety will be described by treatment arm. Initial characteristics of best response and toxicities will be evaluated using usual statistics: for quantitative variables: mean, standard deviation, median, interquartile interval and range and for qualitative variables: frequencies and percentages. For the primary evaluation end point, a one-sided 95% confidence interval (CI) will be calculated in the experimental arm.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Principal objective: • To evaluate the survival of patients at 9 months Secondary objectives: Progression-free survival (PFS) (clinical and/or radiological) Overall survival (OS) Best response rate during treatment according to RECIST 1.1 criteria (according to the investigator and the centralised r...
Principal objective: • To evaluate the survival of patients at 9 months Secondary objectives: Progression-free survival (PFS) (clinical and/or radiological) Overall survival (OS) Best response rate during treatment according to RECIST 1.1 criteria (according to the investigator and the centralised review committee) Toxicity (NCI CTC 4.0) Quality of life (QLQ-C30 and OES18 questionnaires of the EORTC) Arm A (experimental arm): Nal IRI plus LV5-FU (D1=D28) Nal-IRI: 80 mg/m² intravenous over 90 minutes Followed by intravenous folinic acid 400 mg/m² over 30 minutes or L-folinic acid: 200 mg/m² over 30 minutes And then 5-FU 2,400 mg/m² over 46 hours on D1 to D14 Patients known to be homozygous for the UGT1A1*28 allele who are to be randomized to the Nal-IRI/5-FU Arm receive the first cycle of therapy with a reduced dose of Nal IRI of 60 mg/m2. If the patient does not present any toxicity related to the medicinal product after the first administration of Nal IRI, the dose can be increased to 80 mg/m2 starting with cycle 2. Arm B (control arm): PACLITAXEL (D1=D28) Paclitaxel: 80 mg/m² at D1, D8 and D15 Patients will be randomized in a 1:1 ratio using the minimisation technique. Randomisation will be stratified based on the following factors: Centre WHO performance status: 0/1 versus 2 An analysis of circulating tumour DNA (using genetic mutations, in particular, TP53, and DNA methylation analyses) will be performed before the 1st cycle of treatment and at D28, in order to look for factors predictive of response to treatment (decrease in unbound DNA).
Tracking Information
- NCT #
- NCT03719924
- Collaborators
- Shire
- Investigators
- Principal Investigator: DAVID TOUGERON PRODIGE 62 - FFCD 1701
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