Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal S… (NCT03719924) | Clinical Trial Compass
CompletedPhase 2
Nal-iri/lv5-fu Versus Paclitaxel as Second Line Therapy in Patients With Metastatic Oesophageal Squamous Cell Carcinoma
France106 participantsStarted 2019-03-07
Plain-language summary
The aim of our study is to evaluate the efficacy and safety of NALIRI plus 5FU versus paclitaxel as a second-line therapy in patients with locally advanced or metastatic ESCC who had failed to cisplatin- or oxaliplatin-based first-line chemotherapy.
The hypotheses are as follows:
H0: the percentage of patients alive at 9 months of 40% is not useful. H1: the percentage of patients alive at 9 months of 60% is expected.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically proven metastatic oesophageal squamous cell carcinoma
* Patient in failure with 1st-line treatment with oxaliplatin or cisplatin. Patients presenting with resectable disease treated with surgery or neoadjuvant or adjuvant chemotherapy with oxaliplatin or cisplatin (with or without radiotherapy) can be included if a recurrence has occurred less than 6 months after the end of treatment
* Age ≥ 18 years
* Unresectable disease, measurable or not, according to RECIST 1.1 criteria
* WHO performance status ≤ 2
* Neutrophils ≥ 1500/mm3 (without use of haematopoietic growth factors), platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dl (blood transfusions are authorised for patients with a haemoglobin less than 9 g/dl)
* Total bilirubin ≤ 2 x ULN (biliary drainage is authorised in case of a biliary obstruction); albumin ≥ 25 g/L; AST ≤ 2.5 x ULN, and ALT ≤ 2.5 x ULN (≤ 5 x ULN in case of hepatic metastases)
* Creatinine clearance ≥ 50 ml/min according to MDRD formula
* A normal ECG or ECG with no clinically significant findings
* Patient able to understand and to sign the informed consent form (or who has a legal guardian able to do so for him/him)
* Women of childbearing potential must have a negative pregnancy blood or urine test within 7 days prior to inclusion
* Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study a…
What they're measuring
1
survival at 9 months
Timeframe: 9 months
Trial details
NCT IDNCT03719924
SponsorFederation Francophone de Cancerologie Digestive