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

NCT00916708 | Unknown DMC

• 1 other identifier: TOTEM
• Study Type: interventional
• Target: 1,884
• Locations: 1 country
• Sites: 1

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 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:
• Minimalist (Arm 1)
• Intensive (Arm 2)

Conditions

Endometrial Cancer

Keywords

endometrial cancer; follow up; relapse

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Seven years

Secondary Outcomes (4)

• Progression-free survival

  Seven years

• Proportion of complications, second cancers, co-morbidity

  Seven years

• Proportion of asymptomatic patients with diagnosis of relapse

  Seven years

• Proportion of subjects who complete the two different regimes follow up

  Seven years

Study Arms (2)

Intensive follow up

EXPERIMENTAL

Intensive follow up in low-risk patients Intensive follow up in high-risk patients

Procedure: Intensive/Low-Risk follow up (IA G1; IA G2); Procedure: Intensive/High-Risk follow up (≥ IA G3)

Minimalist follow up

EXPERIMENTAL

Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients

Procedure: Minimalist/Low-Risk follow up (IA G1; IA G2); Procedure: Minimalist/High-Risk follow up (≥ IA G3)

Interventions

Intensive/Low-Risk follow up (IA G1; IA G2) PROCEDURE

\- First 2 years of FU since the end of primary treatment: clinical visit\* every 4 months; Pap tests; chest, abdomen, pelvis CT every 12 months \- Since the third to the fifth year of FU: clinical visit\* every 6 months; Pap test every 12 months \* clinical visit with gynecological exploration

Intensive follow up

Intensive/High-Risk follow up (≥ IA G3) PROCEDURE

\- First 3 years of FU since the end of primary treatment: clinical visit\*, Ca125, trans-vaginal and abdominal ultrasound every 4 months (except in conjunction with TC); Pap smear, abdomen, pelvis CT every 12 months \- In the fourth and fifth years of FU: clinical visit\*, Ca125, trans-vaginal and abdominal ultrasound every 6 months (except in conjunction with TC) Pap smear; chest, abdomen, pelvis CT every 12 months \* clinical visit with gynecological exploration

Intensive follow up

Minimalist/Low-Risk follow up (IA G1; IA G2) PROCEDURE

\- First 5 years of FU since the end of primary treatment: clinical visit\* every 6 months. \* clinical visit with gynecological exploration

Minimalist follow up

Minimalist/High-Risk follow up (≥ IA G3) PROCEDURE

\- First 2 years of FU since the end of primary treatment: clinical visit\* every 4 months; chest, abdomen, pelvis CT every 12 months \- Since the third to the fifth year of surveillance: clinical visit\* every 6 months. \* clinical visit with gynecological exploration

Minimalist follow up

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera San Giovanni Battista: lead
• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte: collaborator
• Rete Oncologica Piemonte, Valle d'Aosta: collaborator

Study Sites (1)

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, 10100, Italy

Location

Related Publications (7)

• Gadducci 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 BACKGROUND

• Zanagnolo 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 BACKGROUND

• Zola 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 BACKGROUND

• Zola 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 BACKGROUND

• Gadducci 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 BACKGROUND

• Rosato 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.

  PMID: 38309033 DERIVED

• Zola P, Ciccone G, Piovano E, Fuso L, Di Cuonzo D, Castiglione A, Pagano E, Peirano E, Landoni F, Sartori E, Narducci F, Bertetto O, Ferrero A; TOTEM Collaborative Group. Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial. J Clin Oncol. 2022 Nov 20;40(33):3817-3827. doi: 10.1200/JCO.22.00471. Epub 2022 Jul 20.

  PMID: 35858170 DERIVED

Related Links

• The recruitment of patients has to be registered on the website (http://www.epiclin.it). On the website patients are randomized and crf are available to register follow up appointment

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Zola, MD

  Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paolo Zola MD, Study Coordinator

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 9, 2009
• Study Start: September 1, 2008
• Primary Completion: July 31, 2018
• Study Completion: December 1, 2020
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)