Proton Radiation for Unresectable, Borderline Resectable, or Medically Inoperable Carcinoma of the Pancreas

Official record

Identifier

NCT02598349

Recruiting locations

country

United States

Interventions studied

Proton RadiationCapecitabineSurgical resection

Lead sponsor

Proton Collaborative Group

Target enrolment

60 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Nov 5, 2015

Last updated on the registry

Sep 29, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Biopsy proven unresectable adenocarcinoma of the pancreas.
* Have either unresectable, borderline resectable or medically inoperable carcinoma of the pancreas, or refusing surgery.
* A biliary obstruction is able to participate as long as a drainage tube is in place prior to starting treatment with Proton radiation,
* Participants of child-producing potential must be willing to use contraception while on treatment and for at least 12 months thereafter.
* Required pretreatment laboratory parameters:

  * Absolute granulocyte count (AGC/ANC) ≥ 1.8 thou/mm3
  * Platelet count ≥ 100,000/mm3
  * Bilirubin \< 2 mg/dl
  * ALT/SGPT \< 3x upper limit of normal
  * Creatinine \< 3 mg/dl

Exclusion Criteria:

* Evidence of distant metastasis.
* Prior surgical resection.
* Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the participant has been disease free for 5 years prior to registration.
* Active or untreated infection,
* Pregnant or breastfeeding women or subjects of child producing potential not willing to use medically acceptable contraception while on treatment and for at least 12 months thereafter.
* Previous Radiation to the abdomen.

Indexed under

Pancreatic Cancer