Status:
UNKNOWN
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
Lead Sponsor:
Azienda Ospedaliera San Giovanni Battista
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Rete Oncologica Piemonte, Valle d'Aosta
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 consen...
Detailed Description
The procedure for centralized randomization, with blocks of variable length, will take place within each layer with 1:1 ratio and will be implemented within the centralized database, with sequences ge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
1884 Patients enrolled
Trial Details
Trial ID
NCT00916708
Start Date
September 1 2008
End Date
December 1 2020
Last Update
August 2 2018
Active Locations (1)
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1
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Italy, 10100