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Trial Summary

Protocol No.RTOG-0848
StatusOPEN TO ACCRUAL
Principal InvestigatorEllsworth, Susannah
ScopeNational
PhasePhase III
Age GroupAdult
TitleA Phase II-R and A Phase III Trial Evaluating Both Erlotinib (PH II-R) and Chemoradiation (PHIII) as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
DescriptionThis randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection (i.e., removal of all gross tumor) involving a classic pancreaticoduodenectomy (Whipple) or a pylorus preserving pancreaticoduodenectomy; patients with invasive adenocarcinoma that also contains a component of intraductal papillary mucinous neoplasm (IPMN) are eligible
  • For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesPancreatic Cancer
Participating InstitutionsIndiana University (IU)
  • IU Health Methodist Hospital
  • IU Health West (For use by Cancer Center CTO only)
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu