Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Gary Yang, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01683422
First received: February 17, 2012
Last updated: April 11, 2014
Last verified: April 2014

February 17, 2012
April 11, 2014
December 2011
December 2015   (final data collection date for primary outcome measure)
To determine the one-year survival rate [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01683422 on ClinicalTrials.gov Archive Site
To evaluate the frequency of serious adverse events [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer
A Phase II Trial of Gemcitabine and Erlotinib (GE) Plus Proton-chemotherapy (PCT) and Capox for Locally Advanced Pancreatic Cancer (LAPC)

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • 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
Experimental: Proton Radiation
Interventions:
  • Radiation: Proton, Gemcitabine, Erlotinib, Capecitabine
  • Radiation: Proton Radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
43
December 2017
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Gary Yang, MD 909-558-4280 gyang@llu.edu
Contact: First Call: Proton Referral RN Backup: Sandi Teichman 1 800 776-8667 scteichm@llu.edu
United States
 
NCT01683422
5110324
Yes
Gary Yang, MD, Loma Linda University
Loma Linda University
Not Provided
Principal Investigator: Gary Yang, MD Loma Linda University
Loma Linda University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP