CompletedPhase 1

Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source

United States2 participantsStarted 2017-09-06

Plain-language summary

This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject signed informed consent * Age \>/= 18 years * Biopsy confirmed adenocarcinoma pancreatic cancer * Patient capable of undergoing anesthesia * Patient is a surgical candidate * Patient selected to undergo pancreatic cancer resection * Patient will have known or suspected close/positive surgical margin * Confirmed diagnosis of resectable pancreatic adenocarcinoma * Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle Exclusion Criteria: * Pregnant or breast feeding * Patient has metastatic disease * Patient has had prior radiation therapy to the region for separate cancer * Patient has had prior chemotherapy * Any other invasive cancer in the past 5 years, except basal cell skin * Recurrent or previously resected tumors * Alcoholism/Drug abuse

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale

Timeframe: 1.5 years

Trial details

NCT IDNCT03109041

SponsorCivaTech Oncology

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Pancreas Cancer trials