Pulse-low-dose Rate (PLDR) Radiation in Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04452357|
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: PLDR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RT-155: Utilizing Pulsed Low-dose-rate (PLDR) Radiation to Prevent de Novo Stromal Activation; a Neoadjuvant Pancreatic Adenocarcinoma Phase I Trial|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: PLDR Chemoradiation
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
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
- Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation. [ Time Frame: 11 weeks ]umber of participants with Grade 3 toxicity related to the treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452357
|Contact: Joshua Meyer, MD||215-728-2667||Joshua.Meyer@fccc.edu|
|Contact: Meghann Hainsworth||215-728-5506||Meghann.Hainsworth@fccc.edu|