A Phase IIR and a Phase III Trial Evaluating Both Erlotinib (Ph IIR) And Chemoradiation (Ph III) As Adjuvant Treatment For Patients With Resected Head Of Pancreas Adenocarcinoma
Principal Investigator
Ross Abrams, MD
Status
Closed to Accrual
Date Opened To Accrual
November 17 2009
Disease Site
Gastrointestinal [GI]
Pancreas
Phase
II/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
545
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.