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Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

NCT01389440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-05-18

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Grupo Espanol Multidisciplinario del Cancer Digestivo

    lead OTHER

Principal Investigators

  • Joan Maurel, MD · Hospital Clinic of Barcelona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-11-30
Completion
2017-01-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389440 on ClinicalTrials.gov