Adaptive Radiation For Locally Advanced Unresectable Pancreatic Cancer

Study Overview

Adaptive Radiation for Locally Advanced Unresectable Pancreatic Cancer

The goal of this clinical trial is to learn if Adaptive Radiation Therapy (ART) is safe and effective in treating patients with locally advanced pancreatic cancer. The main questions the study aims to answer are: * Can ART improve how well radiation therapy targets the most aggressive cancer cells, while protecting the healthy tissue around the tumor? * Can ART help reduce the side effects that participants may experience during treatment? Participants will: * Undergo CT scans to plan the exact location of the radiation treatment. During this process, 1-3 small markers may be placed in or near the tumor to help with the planning. * Have a tumor biopsy, which involves taking a small sample of tissue from the cancer. * Receive 5 radiation treatments every other day over a 2-week period. * Provide blood samples before, during, and after your radiation treatment.

N/A

Locally Advanced Pancreatic Ductal Adenocarcinoma (PDA)

RADIATION: Adaptive Radiation Therapy

RT-221

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-05-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-20
First Submitted that Met QC Criteria 2025-05-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-22
First Posted (ACTUAL) 2025-05-22	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Single-Arm Adaptive Radiation Therapy	RADIATION: Adaptive Radiation Therapy Adaptive Radiation Therapy (ART) creates a personalized radiation plan for each treatment session. This means the plan can change from day to day to more precisely target the tumor while protecting the surrounding healthy tissue. By closely shaping the r

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Single-Arm

Adaptive Radiation Therapy

RADIATION: Adaptive Radiation Therapy

Adaptive Radiation Therapy (ART) creates a personalized radiation plan for each treatment session. This means the plan can change from day to day to more precisely target the tumor while protecting the surrounding healthy tissue. By closely shaping the r

Primary Outcome Measures	Measure Description	Time Frame
The rate of acute and late grade ≥3 gastrointestinal toxicity occurring within 3 months of treatment possibly, probably or definitely related to radiation.		From start of radiation to 3 months after the end of radiation treatment

Secondary Outcome Measures	Measure Description	Time Frame
The proportion of patients experiencing local control defined as stable disease or any response at the radiation target site(s).		From the start of radiation to 5 years after end of radiation treatment
Overall Survival Rate - defined as the time from the start of radiation to death or last contact. Individuals who are alive at last follow-up will be considered censored at the time of last contact.		From the start of radiation to death or last contact (up to 5 years after end of treatment).
The rate of acute and late adverse events at time points prescribed in the study calendar using CTCAE version 5.0.		From start of radiation to end of long-term follow up (up to 5 years)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Joshua Meyer, MD

Phone Number: 215-728-2667

Email: Joshua.Meyer@fccc.edu

Study Contact Backup

Name: Jianli Hu, MD, PhD

Phone Number: 267-449-1431

Email: jianli.hu@fccc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

ANC ≥ 1,500/µl and PLT ≥ 100,000/µl
Bilirubin less than 1.5 ULN
AST and ALT < 3X ULN
Serum Creatinine <1.5X ULN 6. Women of childbearing potential must not be pregnant (negative pregnancy test within 72 hours prior to registration). Postmenopausal woman must have been amenorrheal and non-lactating for at least 12 months to be considered of non-childbearing potential. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for at least 6 months after therapy is completed. 7. Age ≥ 18 years 8. Participants must sign a written informed consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment, tissue sample collections, and follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Joshua Meyer, MD, Fox Chase Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record