NCT04452357

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

RT-155: Utilizing Pulsed Low-dose-rate (PLDR) Radiation to Prevent de Novo Stromal Activation; a Neoadjuvant Pancreatic Adenocarcinoma Phase I Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 providing margin adjacent to un-resectable vessels and sterilizing regional lymph nodes. Unfortunately, due to the radiosensitivity of adjacent small bowel and stomach, the total dose of radiation used is modest due to the risk of toxicities associated with higher doses. Pulsed low-dose-rate (PLDR) radiation improves the safety of radiation through breaking it up into small pulses. This increases the repair of DNA damage in normal tissues while remaining effective in cancer cells. Multiple prior studies have shown PLDR to be safe in the setting of re-irradiation, where additional radiation with conventional techniques is associated with severe toxicity. PLDR radiation will be given in 2 doses to 6 patients at each dose level: Dose level 1: 56 Gy- given over 6 weeks Dose level 2: 66 Gy- given over 7 weeks Standard chemotherapeutic drug, gemcitabine, will be administered once a week for the duration of radiation. This treatment will be followed by standard surgery to remove the cancer after consultation with a surgeon.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	PLDR	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

Timeline

• Start date: 2020-01-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-06-30
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study