Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01553019

Acronym

PC03

Enrollment

Registered

2012-03-13

Start date

2011-10-31

Completion date

2017-08-31

Last updated

2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Proton radiation, Chemotherapy, Pancreatic cancer, Postoperative

Brief summary

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.

Detailed description

Proton radiation with concomitant chemotherapy

Interventions

RADIATIONProton radiation

Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction

DRUGGemcitabine

Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Radiation Toxicity	90 days after completion of RT	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.

Secondary

Measure	Time frame	Description
Survival Rate	1 year after completion of RT	One year overall survival rate
Response rate via CA 19-9	Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026