CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas (SENECA)
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|ClinicalTrials.gov Identifier: NCT03387592|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : February 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma||Drug: CPT-11 Drug: Calcio levofolinate Drug: 5-Fluorouracil Drug: Capecitabine Drug: Temozolomide||Phase 2|
This is a multicenter randomized phase II non comparative study. Patients with metastatic NEC G3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment The primary objective is to assess DCR and the safety as co-primary objective. The secondary objectives are: OS, PFS, quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.
The secondary exploratory objectives are the assessment of the impact of PET with gallium on PFS and the evaluation of biomarkers
- Oxaliplatin (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by
- Calcio levofolinate 200 mg/m2, given as a 2h i.v. infusion on days 1 every 2 weeks followed by
- 5-Fluorouracil 400 mg/m2 given as bolus, and then 5-Fluorouracil 2400 mg/m2 given as a 48 h continuous infusion on day 1, every 2 weeks, until progression or for a maximum of 12 cycles
CAPTEM regimen Capecitabine 750 mg/m2 twice a day on days 1-14 in combination with temozolomide 200 mg/m2 daily on days 10-14, every 4 weeks, until progression or for a maximum of 6 cycles.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Trial of Capecitabine and Temozolomide (CAPTEM) or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas and Exploratory Analysis of Predictive Role of Positron Emission Tomography (PET) Imaging and Biological Markers|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
Active Comparator: FOLFIRI regimen
CPT-11 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by Calcio levofolinate 200 mg/m2, given as a 2h i.v. infusion on days 1 every 2 weeks followed by 5-Fluorouracil 400 mg/m2 given as bolus, and then 5-Fluorouracil 2400 mg/m2 given as a 48 h continuous infusion on day 1, every 2 weeks, until progression or for a maximum of 12 cycles
Drug: Calcio levofolinate
400 mg/m2 + 2400 mg/m2
Experimental: CAPTEM regimen
Capecitabine 750 mg/m2 twice a day on days 1-14 in combination with Temozolomide 200 mg/m2 daily on days 10-14, every 4 weeks, until progression or for a maximum of 6 cycles
- Disease Control Rate (DCR) [ Time Frame: responses to treatment lasting at least 12 weeks up to 48 months of study period ]DCR is defined as the percentage of patients who have achieved complete, partial response and stable disease lasting for at least 12 weeks. DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).
- Incidence of treatment related adverse events [ Time Frame: up to 60 months ]Acute treatment related adverse events and late treatment related adverse events will be evaluated; the late treatment related adverse events is the adverse event that occurred after 30 days from the last treatment cycle. The adverse events will be evaluated according to CTCAE Version 5.0.
- Overall Survival (OS) [ Time Frame: up to 60 months ]Overall Survival (OS) is defined as the time from treatment start to the time of death from any cause. Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.
- Progression Free Survival (PFS) [ Time Frame: up to 60 months ]Progression free survival is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.
- Objective response rate (ORR) [ Time Frame: responses to treatment lasting at least 12 weeks up to 60 months of study period ]ORR is defined as the percentage of patients who have achieved complete and partial response for at least 12 weeks from therapy start.
- Quality of Life Questionnaire (QLQ) [ Time Frame: up to 60 months ]Quality of life will be evaluated through validated standardized data collection forms from the EORTC QLQ-C30 questionnaire (quality of life questionnaire). Scoring of global health status, functional scales and symptom scales will be calculated according to EORTC QLQ-C30 Scoring Manual.
- Evaluation of biomarkers [ Time Frame: up to 60 months ]testing for mutational status of Multiple endocrine neoplasia, type 1 (MEN1), death-domain-associated protein (DAXX), α thalassemia/mental retardation syndrome X-linked (ATRX) and Retinoblastoma 1 (RB-1) on primary tumors tissues and for miRNA on blood samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387592
|Contact: Toni Ibrahim, MD||+39 0543 firstname.lastname@example.org|
|Contact: Oriana Nanni||+39 0543 email@example.com|
|Principal Investigator:||Toni Ibrahim, MD||Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)|