Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01683422
Recruitment Status : Recruiting
First Posted : September 11, 2012
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
Gary Yang, MD, Loma Linda University

Brief Summary:
The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine Radiation: Proton Radiation Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)
Study Start Date : December 2011
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Proton Radiation Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine

Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.

Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles.

Radiation: Proton Radiation

Primary Outcome Measures :
  1. To determine the one-year survival rate [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To evaluate the frequency of serious adverse events [ Time Frame: Ongoing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas
  • AJCC stage I-III with unresectable or borderline unresectable disease as defined by NCCN guidelines
  • Radiological resectability is defined by the following criteria on abdominal imaging:

    1. No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery.
    2. No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
    3. No evidence of visceral or peritoneal metastases
  • Borderline and Unresectable cases would be defined as those that do not meet the criteria in section and also show no evidence of distant metastatic or intraperitoneal disease.
  • Eastern Cooperative Oncology Group performance status of ≤ 2
  • Age > 18 years
  • Adequate hematologic reserve, hepatic reserve and renal function
  • WBC > 2,000 cells/mm3
  • ANC > 1,500 cells/mm3
  • Platelets > 100,000 cells/mm3
  • Serum bilirubin ≤ 2.5 mg/dL
  • Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min
  • ALT < 3 times ULN
  • AST < 3 times ULN
  • Albumin > 3.2 g/dl
  • Patient must sign study-specific informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01683422

Contact: Bernadette Bautista, RN 800-496-4966 or 909-558-4000 ext 88213
Contact: Gary Yang, MD Back-up: Sandi Teichman, RN ext 909-558-8231

United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Gary Yang, MD    909-558-4280   
Contact: Proton Referral    1 800 496-4966      
Principal Investigator: Gary Yang, MD         
Sponsors and Collaborators
Loma Linda University
Principal Investigator: Gary Yang, MD

Responsible Party: Gary Yang, MD, MD, Principal Investigator, Loma Linda University Identifier: NCT01683422     History of Changes
Other Study ID Numbers: 5110324
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors