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Clinical trial · no report yet · Phase 3

NCT01013649

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

  • NCT01013649 ↗
  • Completed
  • National Cancer Institute (NCI)
  • 47 commentary sources found
  • Deep

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads39
YouTube3
Podcasts3
X videos2

The trial

ClinicalTrials.gov
Official title
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
Phase
Phase 3
Status
Completed
Conditions
Pancreatic Adenocarcinoma; Pancreatic Ductal Adenocarcinoma; Pancreatic Intraductal Papillary-Mucinous Neoplasm; Stage I Pancreatic Cancer AJCC v6 and v7; Stage II Pancreatic Cancer AJCC v6 and v7
Interventions
3-Dimensional Conformal Radiation Therapy; Biospecimen Collection; Capecitabine; Chemotherapy; Computed Tomography; Erlotinib Hydrochloride; Fluorouracil; Gemcitabine Hydrochloride; Intensity-Modulated Radiation Therapy; Magnetic Resonance Imaging; Quality-of-Life Assessment; X-Ray Imaging
Arms
  • Arm I (gemcitabine hydrochloride or combination chemotherapy) · Active comparator
  • Arm II (gemcitabine hydrochloride, erlotinib hydrochloride) · Experimental
  • Arm III (chemotherapy) · Experimental
  • Arm IV (chemotherapy, chemoradiotherapy) · Experimental
Enrollment
546
Primary outcomes
  • Overall Survival (Percentage of Participants Alive) [Phase II]
  • Overall Survival (Percentage of Participants Alive) [Phase III]
Sponsor
National Cancer Institute (NCI) with NRG Oncology
Start
Apr 5, 2010
Primary completion
Dec 10, 2023
Results posted
Yes
Registry record
NCT01013649 · updated Feb 23, 2026

Publications

linked from the registry
  • Abrams RA, Winter KA, Goodman KA, Regine WF, Safran HP, Guha CS, Kachnic LA, Gillin MT, Philip PA, Lowy AM, O'Reilly E, Van Laethem JL, Seaward SA, Wu AJ, Wu JJ, Aljumaily RM, DiPetrillo TA, Geva R, Anne PR, Liles DK, Ling DC, Conlin A, Moughan J, Crane CH. Adjuvant Chemotherapy +/- Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848. J Clin Oncol. 2026 Aug 20;44(24):2316-2328. doi: 10.1200/JCO-25-02520. Epub 2026 Jun 9. PubMed 42456089
  • Jethwa KR, Kim E, Berlin J, Anker CJ, Tchelebi L, Abood G, Hallemeier CL, Jabbour S, Kennedy T, Kumar R, Lee P, Sharma N, Small W Jr, Williams V, Russo S. Executive Summary of the American Radium Society Appropriate Use Criteria for Neoadjuvant Therapy for Nonmetastatic Pancreatic Adenocarcinoma: Systematic Review and Guidelines. Am J Clin Oncol. 2024 Apr 1;47(4):185-199. doi: 10.1097/COC.0000000000001076. Epub 2023 Dec 22. PubMed 38131628
  • Tchelebi LT, Winter KA, Abrams RA, Safran HP, Regine WF, McNulty S, Wu A, Du KL, Seaward SA, Bian SX, Aljumaily R, Shivnani A, Knoble JL, Crocenzi TS, DiPetrillo TA, Roof KS, Crane CH, Goodman KA. Analysis of Radiation Therapy Quality Assurance in NRG Oncology RTOG 0848. Int J Radiat Oncol Biol Phys. 2024 Jan 1;118(1):107-114. doi: 10.1016/j.ijrobp.2023.08.014. Epub 2023 Aug 19. PubMed 37598723
  • Conroy T, Lambert A, Ducreux M. Adjuvant and neoadjuvant approaches in pancreatic cancer. Curr Opin Oncol. 2023 Jul 1;35(4):326-333. doi: 10.1097/CCO.0000000000000962. Epub 2023 May 12. PubMed 37222189
  • Batukbhai B, Herman JM, Zahurak M, Laheru DA, Le DT, Wolfgang CL, Zheng L, De Jesus-Acosta A. Survival Outcomes of Adjuvant Chemotherapy Combined With Radiation Versus Chemotherapy Alone After Pancreatectomy for Distal Pancreatic Adenocarcinoma: A Single-Institution Experience. Pancreas. 2021 Jan 1;50(1):64-70. doi: 10.1097/MPA.0000000000001724. PubMed 33370024