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Radiation

PLDR Radiation for Pancreatic Cancer

N/A
Waitlist Available
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Poor performance status not immediately conducive to radical surgery.
Other clinical reasoning by the treating physicians that supports pre-operative chemoradiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights

Study Summary

This trial is testing a new type of radiation therapy called pulsed low-dose rate (PLDR) radiation in combination with the chemotherapeutic drug gemcitabine given weekly along with the radiation.

Who is the study for?
This trial is for adults over 18 with non-metastatic pancreatic cancer not ready for immediate surgery. They may have had prior chemo, but must have a washout period before joining. Participants need to be able to perform daily activities (ECOG status 0-2) and agree to use birth control. Excluded are those with previous radiation therapy for pancreatic cancer, uncontrolled illnesses, or certain conditions like scleroderma.Check my eligibility
What is being tested?
The study tests PLDR radiation combined with the chemotherapy drug gemcitabine in patients with pancreatic adenocarcinoma who can't immediately undergo surgery. The goal is to see if this new type of radiation causes less damage to healthy tissue compared to standard treatments.See study design
What are the potential side effects?
Potential side effects include typical reactions from radiation such as skin irritation, fatigue, nausea, and potential increased risk of infection due to lowered blood counts from chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are not physically able to have a major surgery right now.
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The doctor thinks you should have chemotherapy and radiation before surgery for medical reasons.
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You need to have a way for the doctors to measure your disease using specific criteria.
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You are able to carry out everyday activities without any help or with some limitations.
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Your bone marrow, liver, and kidneys are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute grade 3+ gastrointestinal toxicity possibly, probably or definitely related to radiation.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PLDR ChemoradiationExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,497 Total Patients Enrolled

Media Library

PLDR (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04452357 — N/A
Pancreatic Cancer Research Study Groups: PLDR Chemoradiation
Pancreatic Cancer Clinical Trial 2023: PLDR Highlights & Side Effects. Trial Name: NCT04452357 — N/A
PLDR (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04452357 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for volunteers in this experiment currently?

"Affirmative. Clinical trials' records on clinicaltrials.gov demonstrate that this medical experiment, which was first published on January 13th 2020, is actively recruiting individuals for participation. 12 patients need to be enlisted from a single trial centre."

Answered by AI

Could you provide a numerical estimate of the participants for this clinical research?

"Affirmative. According to the clinicaltrials.gov, this trial is engaging participants. It was first advertised on 13th January 2020 and updated most recently on 18th July 2022; they are recruiting 12 individuals from a single location."

Answered by AI
~0 spots leftby Jun 2024