At a glance
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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
In Brief
A Phase 3 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Biospecimen Collection, and 10 other interventions for Pancreatic Adenocarcinoma and 4 related conditions. Completed, enrolled 546 participants across 689 sites in 4 countries.
Detailed Summary
This 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.
Study Details
Timeline
Interventions
Undergo 3-dimensional conformal radiation therapy
Undergo blood and tissue sample collection
Given PO
Given combination chemotherapy
Undergo CT
Given PO
Given IV
Given IV
Undergo intensity-modulated radiation therapy
Undergo MRI
Ancillary studies
Undergo x-ray imaging