Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer (NCT03121469) | Clinical Trial Compass
CompletedNot Applicable
Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer
France28 participantsStarted 2018-10-25
Plain-language summary
Phase 1/2 study, open, monocenter, non-randomized
Who can participate
Age range
60 Years
Sex
FEMALE
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:
* Patient with grade 1 or 2 invasive ductal adenocarcinoma or ductal carcinoma in situ, regardless of grade (found on mammography by an outbreak of Single microcalcification with a diameter not exceeding 2 cm or a tumor opacity \<2 cm),
* Patient aged 60 years or older (patients 60 years of age in the year may be included);
* Unilateral adenocarcinoma, unifocal, positive HR, non-overexpressed HER-2 - T1 N0 radio-clinical , Operable patient with breast volume compatible with conservative surgery,
* Patients who have been made aware of the information sheet and have given their written signed informed consent.
* Patients benefitting from social health insurance coverage.
Exclusion Criteria:
* Age less than 60 years
* Patient with grade 3 invasive breast carcinoma
* Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
* Metastatic patient
* Multifocal and / or bilateral tumor
* N1 proved by ultrasound guided
* Patient with psychological and / or psychiatric disorders
* Vulnerable patient: a person deprived of liberty by an administrative or judicial decision, a major person who is the object of a legal protection measure or is unable to express his / her consent
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
1
In Vivo Measurement of the Delivered Radiation Dose During Intraoperative Radiotherapy (IORT).
Timeframe: Days 1 during per-Operative radiotherapy
2
Number of Participants With a Compliant Delivered Radiation Dose by Measurement Location.
Timeframe: During surgery (at the time of intraoperative radiotherapy delivery).