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A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Phase II Trial of Postoperative Proton Radiotherapy With Concomitant Chemotherapy for Patients With Resected Pancreatic Adenocarcinoma


Proton radiation with concomitant chemotherapy


Inclusion Criteria:



- Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a
potentially curative resection

- Post resection CA19-9 tumor marker baseline

Exclusion Criteria:

- Previous history of invasive malignancy (except non-melanoma skin cancer and low to
intermediate risk prostate cancer) unless the patient has been disease free for at least 5
years prior to study consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiation Toxicity

Outcome Description:

Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment.

Outcome Time Frame:

90 days after completion of RT

Safety Issue:

Yes

Principal Investigator

Romaine C Nichols, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 1013-PC03

NCT ID:

NCT01553019

Start Date:

October 2011

Completion Date:

February 2022

Related Keywords:

  • Pancreatic Cancer
  • Proton radiation
  • Chemotherapy
  • Pancreatic cancer
  • Postoperative
  • Pancreatic Neoplasms

Name

Location

University of Florida Proton Therapy Institute Jacksonville, Florida  32206