Status:
ACTIVE_NOT_RECRUITING
Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer
Lead Sponsor:
Fox Chase Cancer Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Standard chemoradiation, followed by surgery are standard treatment plan for patients suffering from pancreatic adenocarcinoma. Due to damage to the surrounding healthy tissue caused by standard radia...
Detailed Description
Radiation, combined with radiosensitizing chemotherapies, is often used preoperatively for borderline resectable cases with the intent of facilitating a curative surgical intervention. This includes p...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma.
- Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection. This includes the following:
- Any involvement (defined as loss of fat plane on contrast CT) of any of the following vessels\*:
- Common hepatic artery
- Superior mesenteric artery
- Celiac axis
- Superior mesenteric vein
- Portal vein
- Aorta
- These criteria will be judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
- Poor performance status not immediately conducive to radical surgery
- Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation
- Patients must have evaluable disease as measured by RECIST 1.1 criteria.
- Planned surgical resection at the time of enrollment (may be initially staged as resectable, borderline resectable, or locally-advanced/unresectable).
- Eastern Cooperative Oncology Group, or ECOG, performance status 0-2.
- Adequate bone marrow, hepatic, renal function.
- ANC ³ 1,500/ml and PLT ³ 100,000/ml
- Bilirubin less than 1.5 ULN
- AST and ALT \< 3X ULN
- Serum Creatinine \<1.5X ULN
- Prior chemotherapy allowed, but not mandatory. Patients who have undergone chemotherapy prior to participating in this study must have had a 2 week washout period at the time of signing the consent form.
- Women of childbearing potential must be non-pregnant (negative pregnancy test within 72 hours prior to registration. Postmenopausal woman must have been amenorrheic and nonlactating for at least 12 months to be considered of non-childbearing potential. Men and women of child bearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy is completed. Please refer to section 6.4 for additional detail.
- Age \> 18 years
- Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
Exclusion
- Radiological or cytologically confirmed metastatic disease
- Patients who have had any prior therapy for pancreatic cancer, except chemotherapy (see 6.1.7)
- Concurrent non-study chemotherapy or biologic therapy
- A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
- Scleroderma or active connective tissue disease
- Active inflammatory bowel disease
- Serious, active infections requiring treatment with IV antibiotics
- Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04452357
Start Date
January 13 2020
End Date
December 1 2025
Last Update
July 4 2025
Active Locations (1)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111