Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer

NCT04452357 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: RT-15518-1085
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 radiation, this study uses a new type of radiation plan- pulsed low-dose rate (PLDR) radiation , in combination with chemotherapeutic drug, gemcitabine, given weekly along with the radiation.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.

  Number of participants with Grade 3 toxicity related to the treatment

  11 weeks

Study Arms (1)

PLDR Chemoradiation

EXPERIMENTAL

Patients will receive pulse-low-dose rate radiation, along with gemcitabine chemotherapy. 6 patients each will be accrued at two dose levels. PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy

Radiation: PLDR

Interventions

PLDR RADIATION

PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows: Dose level 1: 56 Gy; Dose level 2: 66 Gy Drug: Gemcitabine

PLDR Chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: January 13, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)