12 Participants Needed

PLDR Radiation for Pancreatic Cancer

JM
MH
Overseen ByMeghann Hainsworth
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fox Chase Cancer Center
Must be taking: Gemcitabine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have had chemotherapy before joining, you must have a 2-week period without it before starting the trial.

What data supports the effectiveness of the treatment PLDR for pancreatic cancer?

Research on similar radiation treatments for pancreatic cancer, like intensity modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT), shows that increasing the radiation dose can improve survival and control the cancer better without causing severe side effects. This suggests that PLDR, which is a type of radiation treatment, might also be effective.12345

Is PLDR radiation generally safe for humans?

PLDR radiation therapy has been shown to reduce the risk of damage to normal tissues compared to other radiation techniques, which suggests it is generally safe for humans. Studies have demonstrated that PLDR can lower the dose received by organs at risk, such as the kidneys and small bowel, in treatments for pancreatic and prostate cancer.678910

How does the PLDR treatment for pancreatic cancer differ from other treatments?

PLDR (Pulsed Low-Dose Rate) radiation therapy is unique because it delivers radiation in smaller, more frequent doses, which may help minimize damage to healthy tissues compared to traditional radiation methods. This approach is different from standard treatments that often use higher doses in fewer sessions.1112131415

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

You are not physically able to have a major surgery right now.
Patients must have non-metastatic pancreatic cancer not appropriate for immediate surgical resection, as judged by the operating surgeon in conjunction with a radiologist prior to enrollment.
You need to have a way for the doctors to measure your disease using specific criteria.
See 14 more

Exclusion Criteria

Concurrent non-study chemotherapy or biologic therapy.
You have not received any treatment for pancreatic cancer, except for chemotherapy.
Uncontrolled intercurrent illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pulsed low-dose-rate (PLDR) radiation and weekly gemcitabine chemotherapy

6-7 weeks
Weekly visits for radiation and chemotherapy

Surgery

Standard surgery to remove the cancer after consultation with a surgeon

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • PLDR
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials
236
Recruited
39,300+

Findings from Research

In a study of 200 patients with locally advanced pancreatic cancer, those receiving dose-escalated intensity modulated radiation therapy (IMRT) with a biologically effective dose (BED) greater than 70 Gy showed significantly improved overall survival (OS) of 17.8 months compared to 15.0 months for those with lower doses.
The higher radiation dose also led to better local-regional recurrence-free survival (RFS) of 10.2 months versus 6.2 months, without increasing toxicity, indicating that dose escalation can be a safe and effective strategy in treatment.
Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation.Krishnan, S., Chadha, AS., Suh, Y., et al.[2022]
Intraoperative radiation therapy (IORT) with electrons was administered to 52 patients with locally advanced pancreatic cancer, showing acceptable acute and chronic tolerance to the treatment.
Local progression of cancer was infrequent (7% in evaluable patients), but there was no significant improvement in median or long-term survival, likely due to the high rates of liver and peritoneal metastases associated with pancreatic cancer.
Intraoperative and external beam irradiation +/- 5-FU for locally advanced pancreatic cancer.Gunderson, LL., Martin, JK., Kvols, LK., et al.[2019]
In a phase I trial involving 37 patients with advanced pancreatic cancer, the maximum-tolerated radiation dose concurrent with full-dose gemcitabine was determined to be 36 Gy, as higher doses (42 Gy) resulted in significant acute and late gastrointestinal toxicities.
The study suggests that while the highest radiation dose tested was not safe, the lower dose of 36 Gy is recommended for further investigation in a phase II trial due to better tolerance and promising survival data.
Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer.McGinn, CJ., Zalupski, MM., Shureiqi, I., et al.[2022]

References

Focal Radiation Therapy Dose Escalation Improves Overall Survival in Locally Advanced Pancreatic Cancer Patients Receiving Induction Chemotherapy and Consolidative Chemoradiation. [2022]
Intensity modulated radiation therapy and chemotherapy for locally advanced pancreatic cancer: results of feasibility study. [2022]
Dose Escalation in Stereotactic Body Radiation Therapy for Pancreatic Cancer: A Meta-Analysis. [2019]
Induction Chemotherapy and Ablative Stereotactic Magnetic Resonance Image-Guided Adaptive Radiation Therapy for Inoperable Pancreas Cancer. [2022]
Hypofractionated sequential radiotherapy boost: a promising strategy in inoperable locally advanced pancreatic cancer patients. [2022]
A model-based patient selection tool to identify who may be at risk of exceeding dose tolerances during pancreatic SBRT. [2020]
A dosimetric model of duodenal toxicity after stereotactic body radiotherapy for pancreatic cancer. [2022]
Dose evaluations of organs at risk and predictions of gastrointestinal toxicity after re-irradiation with stereotactic body radiation therapy for pancreatic cancer by deformable image registration. [2023]
Dosimetric parameters correlate with duodenal histopathologic damage after stereotactic body radiotherapy for pancreatic cancer: Secondary analysis of a prospective clinical trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Intensity-modulated radiation therapy for pancreatic and prostate cancer using pulsed low-dose rate delivery techniques. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Intraoperative and external beam irradiation +/- 5-FU for locally advanced pancreatic cancer. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer. [2022]
Combined isodose curves of high-dose rate interstitial brachytherapy with external-beam radiation therapy in pancreatic carcinoma. [2016]
Dose-painted intensity modulated radiation therapy improves local control for locally advanced pancreas cancer. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Current radiotherapeutic approaches to pancreatic cancer. [2019]
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