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Combined Radiation and Chemotherapy for Pancreatic Cancer

Phase 1
Recruiting
Led By Amol Narang, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Upfront treatment with multi-agent chemotherapy
Candidate for surgical exploration at JHU
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines surgery and radiation therapy.

Who is the study for?
This trial is for adults over 18 with localized pancreatic cancer who can have surgery after chemotherapy and targeted radiation therapy (SBRT). They must be fit enough for the treatment, able to give consent, and not pregnant or causing pregnancy. People with tumors in certain parts of the pancreas, previous similar treatments, or unable to follow the study plan are excluded.Check my eligibility
What is being tested?
The trial tests if adding intraoperative radiation therapy (IORT) right after SBRT and before surgery is safe for patients with pancreatic cancer. It's given during an operation at Johns Hopkins University (JHU) following specific guidelines.See study design
What are the potential side effects?
Potential side effects may include tissue damage around the treated area due to high-dose radiation, complications from surgery such as infection or bleeding, fatigue from combined therapies, and possible impacts on fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving initial treatment with a combination of chemotherapy drugs.
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I am eligible for a surgery assessment at JHU.
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I can take care of myself and am up and about more than half of the day.
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I am older than 18 years.
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My pancreatic cancer is considered operable according to NCCN guidelines.
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I am a candidate for a specific radiation therapy at JHU.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months 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 post-operative toxicity of targeted IORT
Secondary outcome measures
Late post-operative toxicity of targeted IORT
Median local-progression free survival (LPFS) from IORT
Median overall survival (OS) from IORT
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intra Operative Radiation Therapy (IORT) GroupExperimental Treatment1 Intervention
The IORT group is the single arm of this study. Enrolled patients who undergo standard of care treatment will also receive a study treatment of High Dose Rate (HDR) Intra Operative Radiation Therapy.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,855 Total Patients Enrolled
Amol Narang, MDPrincipal InvestigatorJHU, School of Medicine, SKCCC
3 Previous Clinical Trials
54 Total Patients Enrolled

Media Library

Intra Operative Radiation Therapy (IORT) Group Clinical Trial Eligibility Overview. Trial Name: NCT05141513 — Phase 1
Pancreatic Cancer Research Study Groups: Intra Operative Radiation Therapy (IORT) Group
Pancreatic Cancer Clinical Trial 2023: Intra Operative Radiation Therapy (IORT) Group Highlights & Side Effects. Trial Name: NCT05141513 — Phase 1
Intra Operative Radiation Therapy (IORT) Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05141513 — Phase 1

Frequently Asked Questions

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

How many individuals are enrolled in the trial at this juncture?

"Affirmative. According to clinicaltrials.gov, this research project is presently accepting volunteers and was first posted on May 6th 2022. The most recent update came June 3rd 2022 and the trial is currently seeking 25 participants from a single site."

Answered by AI

Is it feasible to join this trial at the present moment?

"Per the records available on clinicaltrials.gov, this trial is presently recruiting participants with an initial posting date of May 6th 2022 and most recent update done on June 3rd 2022."

Answered by AI

Has this medical technique been accepted by the FDA?

"Limited safety and efficacy data suggests that this medication's safety rating on a 1 - 3 scale is approximately 1. This evaluation stems from it being in its early Phase 1 trial stage."

Answered by AI
~2 spots leftby Jun 2024