Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Phase 2 Completed 24 enrolled Grupo Espanol Multidisciplinario del Cancer Digestivo

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.

Timeline

Start: 2011-05
Primary completion: 2016-11
Completion: 2017-01-22

Outcome

Missed primary endpoint

paper Resectability rate was 76%, with a R0 rate of 63.1% among the resected patients. PMID 30225601 ↗

Publications

Maurel J, Sanchez-Cabus S, Laquente B, Gaba L, Visa L, Fabregat J, Poves I, Rosello S, Diaz-Beveridge R, Martin-Richard M, Rodriguez J, Sabater L, Conill C, Cambray M, Reig A, Ayuso JR, Valls C, Ferrandez A, Bombi JA, Gines A, Garcia-Albeniz X, Fernandez-Cruz L. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine-erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial). Cancer Chemother Pharmacol. 2018 Dec;82(6):935-943. doi: 10.1007/s00280-018-3682-9. Epub 2018 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	100 mg	—
Subject	Gemcitabine	Small molecule	300 mg/m2	—