RTOG-0848

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma

Principal Investigator

Ross A. Abrams

Status

Disease Site

Gastrointestinal [GI] Pancreas

Phase

III

Developmental Therapeutics

No

Primary Objective

PhII-R: To determine whether the addition of erlotinib to gemcitabine adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). 

Ph III-To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy.

Protocol and Other Documents:

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website

NRG-RTOG 0848 Webinar (06/23/2017) Recording 
PLEASE NOTE: Video starts at 3:40 due to technical difficulties.

NRG-RTOG 0848 Webinar (06/23/2017) Slide Set

Data Collection Notice:

Data for this trial is being collected via the NRG/RTOG Data Center.

Patient Population

Resected head of pancreas adenocarcinoma. This includes the pancreatic head, uncinate process, and neck of the pancreas, status post a curative-intent pancreaticoduodenectomy

Target Accrual

950