This study is currently not recruiting participants.

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

Investigating Treatment Options for Pancreatic Cancer After Surgery

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

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.

Detailed description of study

The purpose of this study is to determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) 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); to determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine based chemotherapy or non-gemcitabine based chemotherapy such as modified fluorouracil-leucovorin-irinotecan-oxaliplatin regimen (FOLFIRINOX) further enhances survival for such patients who are without evidence of progressive disease after 5 months of adjuvant chemotherapy

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: pancreatic cancer
  • Age: 18 years - 100 years
  • Gender: All

This study investigates treatments for patients with pancreatic cancer who have had their cancer removed by surgery. The purpose is to see if adding an investigational medication to a standard chemotherapy medicine can improve survival. The study looks at different combinations of chemotherapy with or without radiation therapy to find the best approach for these patients.

Participants will receive chemotherapy treatments, and some may also receive radiation therapy. The study involves comparing these different treatment arms to understand which combination works better for improving patient outcomes.

  • Who can participate: Participants must be adults who have had pancreatic cancer removed by surgery. Additional eligibility criteria include age requirements and other health factors as determined by the study protocol.
  • Study details: Participants will be assigned to different treatment arms, receiving either chemotherapy alone or chemotherapy with radiation therapy. They will receive specific chemotherapy treatments and may also undergo radiation therapy. A placebo is not used in this study.
Updated on 19 Feb 2024. Study ID: 1706069284 (RTOG-0848)

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