REtroperitoneal SArcoma Registry: an International Prospective Initiative (NCT03838718) | Clinical Trial Compass
RecruitingNot Applicable
REtroperitoneal SArcoma Registry: an International Prospective Initiative
United States, Australia, Canada2,000 participantsStarted 2016-09-01
Plain-language summary
Surgery is currently the only potentially curative treatment modality for localized retroperitoneal sarcoma (RPS). Available studies regarding oncologic outcomes are mainly retrospective in nature, and RPS are recognized as a rare disease. Therefore, prospective analysis of high quality data is a top priority.
Primary Objectives of this study are:
* to prospectively collect standardized clinical data and radiological and pathological material from primary RPS patients treated with surgery at reference centers.
* patient outcome will be evaluated in terms of overall survival (OS), disease-free survival (DFS), crude cumulative incidence (CCI) of local recurrence (LR) and distant metastasis (DM).
Secondary Objectives:
* to estimate the efficacy and safety of surgical treatment, including extended surgical approach to primary RPS;
* to prospectively evaluate the impact of multimodality therapy, including radiation therapy and chemotherapy;
* to identify clinical, radiological and pathological characteristics that may influence the oncological outcome or may be used as predictors of LR/DM/OS. These may be important biomarkers of disease;
* to utilize collected pathological material for research collaborations.
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:
* primary RPS operated on in the participating center;
* age\>18 years at the time of the first treatment (pediatric patients can not be included)
* histological confirmed diagnosis according to the WHO criteria done on biopsy or surgical specimen by dedicated sarcoma pathologist;
* radiological examinations performed (contrast enhanced abdominal CT scan and/or MRI) prior to surgical resection;
* signed informed consent form;
* adequate compliance of the patients to the plan of follow-up
Exclusion Criteria:
* age\<18 years;
* recurrent tumor;
* benign retroperitoneal tumors;
* serious psychiatric disease that precludes informed consent or limits compliance;
* impossibility to ensure adequate follow-up
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
Disease-free Survival
Timeframe: 10 years
Trial details
NCT IDNCT03838718
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano