Clinical trialNCT01013649CompletedPhase 3Interventional

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 Has Been Removed by Surgery

SponsorNational Cancer Institute (NCI)Enrollment546Pancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic Intraductal Papillary-Mucinous NeoplasmStage I Pancreatic Cancer AJCC v6 and v7Stage II Pancreatic Cancer AJCC v6 and v7

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Ross A Abrams
NRG Oncology
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

689 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium

Hospital Univ. Erasme
Brussels, Belgium
University Hospital Saint Luc
Brussels, Belgium
Algemeen Ziekenhuis Groeninge Campus Kennedylaan
Kortrijk, Belgium
Az Turnhout-Campus Saint Elizabeth
Turnhout, Belgium

Canada

London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada
Ottawa Hospital-Civic Campus
Ottawa, Ontario, Canada
Chum - Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada

Israel

Rabin Medical Center
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Israel

United States

Providence Hospital
Mobile, Alabama, United States
Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Community Cancer Institute
Clovis, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Epic Care-Dublin
Dublin, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Kaiser Permanente-Fremont
Fremont, California, United States
Fresno Cancer Center
Fresno, California, United States
Saint Agnes Medical Center
Fresno, California, United States
Marin General Hospital
Greenbrae, California, United States
Uc San Diego Moores Cancer Center
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Los Angeles General Medical Center
Los Angeles, California, United States
Usc / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Kaiser Permanente-Modesto
Modesto, California, United States
Memorial Medical Center
Modesto, California, United States
El Camino Hospital
Mountain View, California, United States

649 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Capecitabine →Chemotherapy →Erlotinib →Fluorouracil →Gemcitabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Apr 2010
Primary completion: 10 Dec 2023
Completion: 4 Sept 2025
Last update posted: 23 Feb 2026
Registered enrollment: 546
Registry id: NCT01013649

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.