drugset / Trial / NCT03387592
CAPTEM or FOLFIRI as SEcond-line Therapy in NEuroendocrine CArcinomas
Phase 2
Terminated
53 enrolled
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized phase II non comparative study. Patients with metastatic Neuroendocrine Carcinomas (NEC) Grade 3, will be enrolled in the study and will be randomly assigned to receive FOLFIRI or CAPTEM as second line treatment. Disease control rate (DCR) and safety are primary objectives, secondary objectives are Disease control rate (OS), Progression Free Survival (PFS), quality of life and toxicity of subsequent line of therapy (after Progression Disease PD) with an observational purpose.
Timeline
- Start
- 2017-03-06
- Primary completion
- 2022-02-28
- Completion
- 2022-02-28
Outcome
Missed primary endpoint
Stopped: “Efficacy endpoint not met according to first step of Briant-Day design”
paper the minimum 12w-DCR threshold of 10 out of 25 patients required for the first step was not reached. PMID 39002347 ↗
Publications
- Bongiovanni A, Liverani C, Foca F, Bergamo F, Leo S, Pusceddu S, Gelsomino F, Brizzi MP, Di Meglio G, Spada F, Tamberi S, Lolli I, Cives M, Marconcini R, Pucci F, Berardi R, Antonuzzo L, Badalamenti G, Santini D, Recine F, Vanni S, Tebaldi M, Severi S, Rudnas B, Nanni O, Ranallo N, Crudi L, Calabro L, Ibrahim T. A randomized phase II trial of Captem or Folfiri as second-line therapy in neuroendocrine carcinomas. Eur J Cancer. 2024 Sep;208:114129. doi: 10.1016/j.ejca.2024.114129. Epub 2024 May 25.
- Bongiovanni A, Liverani C, Pusceddu S, Leo S, Di Meglio G, Tamberi S, Santini D, Gelsomino F, Pucci F, Berardi R, Lolli I, Bergamo F, Ricci S, Foca F, Severi S, Ibrahim T; SENECA Study Team Investigators. Randomised phase II trial of CAPTEM or FOLFIRI as SEcond-line therapy in NEuroendocrine CArcinomas and exploratory analysis of predictive role of PET/CT imaging and biological markers (SENECA trial): a study protocol. BMJ Open. 2020 Jul 19;10(7):e034393. doi: 10.1136/bmjopen-2019-034393.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Calcio levofolinate | Unknown | 200 mg/m2 | Intravenous |
| Subject | Capecitabine | Small molecule | 750 mg/m2 | — |
| Comparator | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 400 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | — |