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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
Gastrointestinal (GI)
Karmanos Trial ID
2021-051
NCT ID
NCT02598349
Age Group
Adult
Scope
National
Phase
Phase II
Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase II
Principal Investigator
Christian
Hyde, M.D., DABR
Oncology - Radiation
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Objective:
Primary Objective:
Improve 12 month survival from 50% to 75%.
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
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
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:
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.
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at McLaren Flint
4100 Beecher Rd
Flint, MI 48532
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Phone:
810-342-3800
Karmanos Cancer Institute at McLaren Lapeer Region
1295 Barry Drive
Lapeer, MI 48446
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Pancreas
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Chemotherapy, Proton Therapy
Drugs
Capecitabine
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