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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Proton Collaborative Group
Study ID
NCT02598349
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proton Radiation — RADIATION
    Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
  • Capecitabine — DRUG
    Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
  • Surgical resection — PROCEDURE
    Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.

Study Details

The prognosis for patients with localized pancreatic adenocarcinoma who are not surgical candidates is poor. Patients characterized as having "borderline resectable" disease treated with preoperative chemo-radiotherapy fair somewhat better - although many of these patients are not converted to resectability. It may be argued that intensification of local and regional therapy might 1.) Increase the share of patients able to undergo curative surgery and 2.) Improve the local disease control interval and extend survival for patients who remain unresectable. Therefore, the purpose of this research study is to determine if an increase in the number of surgical resection pancreatic adenocarcinoma is higher than historical data by using a combined treatment of proton radiation with capecitabine (oral chemotherapy).

Key Dates

Start date
Apr 30, 2016
Status verified
Sep 2025
Primary completion
Oct 31, 2039
Completion
Oct 31, 2040

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Proton Radiation with capecitabine
    The following will be performed in this group: Proton Radiation Therapy with concomitant oral chemotherapy, capecitabine taken on radiation treatment days for 6 weeks. A surgical resection will be performed between 8 and 16 weeks if radiographic studies suggest operability.

Primary Outcome Measure

Overall survival at 12 months after radiation therapy [ Time Frame: Approximately 12 months after radiation therapy. ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Florida Proton Therapy InstituteJacksonvilleFlorida32206-
Northwestern Medicine Chicago Proton CenterWarrenvilleIllinois60555
Don Smith, MS, CCRC
[email protected]
630-933-7820
Nasiruddin Mohammed, MD (PRINCIPAL_INVESTIGATOR)
McLaren Proton Therapy CenterFlintMichigan48532
Taylor Brewer
[email protected]
313-576-8526
Brian Yeh, MD (PRINCIPAL_INVESTIGATOR)
Inova Schar Cancer InstituteFairfaxVirginia22031
Sangeetha Moturi
[email protected]
571-472-0343
Michael Eblan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of Florida Proton Therapy Institute· Jacksonville, FLNorthwestern Medicine Chicago Proton Center· Warrenville, ILMcLaren Proton Therapy Center· Flint, MIInova Schar Cancer Institute· Fairfax, VA

Related Studies