UnknownNot Applicable

Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients

Italy1,884 participantsStarted 2008-09

Plain-language summary

This study aims to compare two different follow up regimens with different test intensity in endometrial cancer treated patients. If eligibility criteria are satisfied and the written informed consensus is obtained, patients are stratified inside the centre according to their risk level: * Group 1 : patients at low risk of recurrence \[stage IA G1 and stage IA G2\] * Group 2 : patients at high-risk of recurrence \[≥ stage IA G3\] (Ethics Committee amendment of 14th September 2010, use new 2010 FIGO classification for endometrial cancer!) In each group patients will be randomized in two regimens of follow up: 1. Minimalist (Arm 1) 2. Intensive (Arm 2) Features of each arm are listed in "Arms" item.

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 treated surgically for endometrial cancer, if in complete clinical remission confirmed by imaging stage FIGO I-IV * no previous or concurrent neoplasia (with the exception of carcinoma in situ of the cervix and basalioma of the skin) * other contemporaneous RCT may be allowed if there is not any restriction concerning follow up * obtaining a written informed consensus before randomization * age \> 18 years Exclusion Criteria: * presence of any psychological, familial, sociological or geographical condition that could potentially limit the compliance to the protocol and the follow-up planned: all these situations must be discussed with the patient before the randomization * previous, concurrent or second malignancies endometrial carcinoma in the context of a hereditary syndrome * conditions which contraindicate medical tests scheduled according to follow-up regimen

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

Overall survival

Timeframe: Seven years

Trial details

NCT IDNCT00916708

SponsorAzienda Ospedaliera San Giovanni Battista

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-31

View on ClinicalTrials.gov More Endometrial Cancer trials