Clinical trial · Interventional
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
Appropriateness Evaluation of Follow up Procedures in Gynaecology Oncology TOTEM Study: Multicentric Randomized Controlled Clinical Trial Between Two Follow up Regimens With Different Tests Intensity in Endometrial Cancer Treated Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive/High-Risk follow up (≥ IA G3) | Procedure | — | UNRESOLVED |
| Intensive/Low-Risk follow up (IA G1; IA G2) | Procedure | — | UNRESOLVED |
| Minimalist/High-Risk follow up (≥ IA G3) | Procedure | — | UNRESOLVED |
| Minimalist/Low-Risk follow up (IA G1; IA G2) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intensive follow up
- description
- Intensive follow up in low-risk patients Intensive follow up in high-risk patients
- interventionNames
- Procedure: Intensive/Low-Risk follow up (IA G1; IA G2)
- Procedure: Intensive/High-Risk follow up (≥ IA G3)
- type
- EXPERIMENTAL
- label
- Minimalist follow up
- description
- Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients
- interventionNames
- Procedure: Minimalist/Low-Risk follow up (IA G1; IA G2)
- Procedure: Minimalist/High-Risk follow up (≥ IA G3)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDGadducci A, Fuso L, Cosio S, Landoni F, Maggino T, Perotto S, Sartori E, Testa A, Galletto L, Zola P. Are surveillance procedures of clinical benefit for patients treated for ovarian cancer?: A retrospective Italian multicentric study. Int J Gynecol Cancer. 2009 Apr;19(3):367-74. doi: 10.1111/IGC.0b013e3181a1cc02. PMID 19407561
- BACKGROUNDZanagnolo V, Minig LA, Gadducci A, Maggino T, Sartori E, Zola P, Landoni F. Surveillance procedures for patients for cervical carcinoma: a review of the literature. Int J Gynecol Cancer. 2009 Apr;19(3):306-13. doi: 10.1111/IGC.0b013e3181a130f3. PMID 19407551
- BACKGROUNDZola P, Fuso L, Mazzola S, Piovano E, Perotto S, Gadducci A, Galletto L, Landoni F, Maggino T, Raspagliesi F, Sartori E, Scambia G. Could follow-up different modalities play a role in asymptomatic cervical cancer relapses diagnosis? An Italian multicenter retrospective analysis. Gynecol Oncol. 2007 Oct;107(1 Suppl 1):S150-4. doi: 10.1016/j.ygyno.2007.07.028. Epub 2007 Sep 14. PMID 17868785
- BACKGROUNDZola P, Fuso L, Mazzola S, Gadducci A, Landoni F, Maggino T, Sartori E. Follow-up strategies in gynecological oncology: searching appropriateness. Int J Gynecol Cancer. 2007 Nov-Dec;17(6):1186-93. doi: 10.1111/j.1525-1438.2007.00943.x. Epub 2007 Apr 26. PMID 17466042
- BACKGROUNDGadducci A, Cosio S, Zola P, Landoni F, Maggino T, Sartori E. Surveillance procedures for patients treated for epithelial ovarian cancer: a review of the literature. Int J Gynecol Cancer. 2007 Jan-Feb;17(1):21-31. doi: 10.1111/j.1525-1438.2007.00826.x. PMID 17291227
- DERIVEDRosato R, Ferrero A, Mosconi P, Ciccone G, Di Cuonzo D, Evangelista A, Fuso L, Piovano E, Pagano E, Laudani ME, Pace L, Zola P; TOTEM Collaborative Group. Impact of different follow-up regimens on health-related quality of life and costs in endometrial cancer patients: Results from the TOTEM randomized trial. Gynecol Oncol. 2024 May;184:150-159. doi: 10.1016/j.ygyno.2024.01.050. Epub 2024 Feb 3.