Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer
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- STATUS
- Recruiting
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- participants needed
- 12
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- sponsor
- Fox Chase Cancer Center
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.
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.
Details
| Condition | Pancreatic Cancer, Pancreatic Cancer, Pancreatic disorder, Neoplasm of unspecified nature of digestive system |
|---|---|
| Age | 18years - 100years |
| Treatment | PLDR |
| Clinical Study Identifier | NCT04452357 |
| Sponsor | Fox Chase Cancer Center |
| Last Modified on | 19 February 2024 |
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