NCT01389440

Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine and Erlotinib	Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-11-01
• Completion: 2017-01-22
• First posted: 2011-07-08
• Last updated: 2018-05-18

Locations

10 sites across 1 country: Spain