RecruitingNot Applicable

Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Italy55 participantsStarted 2021-02-24

Plain-language summary

The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).

Who can participate

Age range

18 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: * Patients ≥ 18 years of age * Karnofsky Index ≥ 70 * Histological or radiological diagnosis of pelvic and groin recurrence * Contraindications for radical surgery * No other distant progression or stable disease (SD) of known secondarisms (≥6 months) * Previous radiation therapy on pelvis * Distance ≥ 10mm between tumour and close intestinal tract (small intestine), radiologically evaluated * Possibility to perform a surgery to space the intestinal loops, in case of distance \< 10mm * If needed, spacer in biocompatible material (silicon, goretex) or anatomical material (omentum, muscle patch), non-absorbable. * DICOM (Digital Imaging and COmmunications in Medicine) images of the previous treatment plan availability * Written informed consent * Patient's ability to understand the characteristics and consequences of the clinical trial Exclusion Criteria: * Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan * Intestinal infiltration * Bladder infiltration * Vessel infiltration * Previous therapy with anti-angiogenesis drugs * Psychic or other disorders that may prevent informed consent * Previous invasive tumor, with the exception of skin cancer (excluding melanoma) unless disease-free for at least 3 years * Spacer in absorbable material (i.e. vycril) * Distance \< 10mm between tumour and close intestinal tract (small intestine),…

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.