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

Status Suspended

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04452357
Study type	Interventional
Source	Fox Chase Cancer Center
Contact
Status	Suspended
Phase	N/A
Start date	January 13, 2020
Completion date	December 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05305001` - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Completed	`NCT02526017` - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers	Phase 1
Recruiting	`NCT05497531` - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers	N/A
Recruiting	`NCT04927780` - Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer	Phase 3
Recruiting	`NCT06054984` - TCR-T Cells in the Treatment of Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT05919537` - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation	Phase 1
Terminated	`NCT03140670` - Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy	Phase 2
Terminated	`NCT00529113` - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer	Phase 1
Recruiting	`NCT05168527` - The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients	Phase 2
Active, not recruiting	`NCT04383210` - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors	Phase 2
Recruiting	`NCT05391126` - GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care	N/A
Terminated	`NCT03300921` - A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer	Phase 1
Completed	`NCT03153410` - Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas	Early Phase 1
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Recruiting	`NCT05679583` - Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer	Phase 2
Recruiting	`NCT04183478` - The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer	Phase 2/Phase 3
Terminated	`NCT03600623` - Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer	Early Phase 1
Recruiting	`NCT04584008` - Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics	N/A
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Completed	`NCT04290364` - Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study