A Phase II Trial of Escalated Dose Proton Radiotherapy with Elective Nodal Irradiation and Concomitant Chemotherapy for Patients with Unresectable, Borderline Resectable or Medically Inoperable Pancreatic Adenocarcinoma

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

Secondary Objectives

Collect and analyze tumor control outcomes:
- Improve local control
- Improve regional disease control
Increase share of marginally resectable and unresectable patients being converted to resectable.
Compare GI toxicity of protocol therapy with historical benchmarks

Eligibility

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:

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

4100 Beecher Rd
Flint, MI 48532
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Phone: 810-342-3800

3520 Forest Rd.
Lansing, MI 48910
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Phone: 517-975-9500

1295 Barry Drive
Lapeer, MI 48446
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices