Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

Sponsor
Grupo Espanol Multidisciplinario del Cancer Digestivo
Study ID
NCT01389440
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine and Erlotinib — DRUG
    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)

Study Details

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.

Key Dates

First listed
Jul 8, 2011
Start date
May 31, 2011
Status verified
Aug 2017
Primary completion
Nov 30, 2016
Completion
Jan 22, 2017

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gemcitabine, Erlotinib and radiotherapy
    Gemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy

Primary Outcome Measure

Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection [ Time Frame: 3 years ]

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