Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients (TOTEM)
Primary Purpose
Endometrial Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intensive/Low-Risk follow up (IA G1; IA G2)
Intensive/High-Risk follow up (≥ IA G3)
Minimalist/Low-Risk follow up (IA G1; IA G2)
Minimalist/High-Risk follow up (≥ IA G3)
Sponsored by
About this trial
This is an interventional other trial for Endometrial Cancer focused on measuring endometrial cancer, follow up, relapse
Eligibility Criteria
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
Sites / Locations
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intensive follow up
Minimalist follow up
Arm Description
Intensive follow up in low-risk patients Intensive follow up in high-risk patients
Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Progression-free survival
Proportion of complications, second cancers, co-morbidity
Proportion of asymptomatic patients with diagnosis of relapse
Proportion of subjects who complete the two different regimes follow up
Full Information
NCT ID
NCT00916708
First Posted
June 8, 2009
Last Updated
August 1, 2018
Sponsor
Azienda Ospedaliera San Giovanni Battista
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Rete Oncologica Piemonte, Valle d'Aosta
1. Study Identification
Unique Protocol Identification Number
NCT00916708
Brief Title
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
Acronym
TOTEM
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 31, 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera San Giovanni Battista
Collaborators
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Rete Oncologica Piemonte, Valle d'Aosta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
Features of each arm are listed in "Arms" item.
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 generated by dedicated software. The recruitment and randomization has to be registered on the website (www.epiclin.cpo.it) no later than 20 days after histological examination has been received. If patients do not need any kind of adjuvant therapy they will start follow-up program according to the regimen chosen for them at randomization, if adjuvant therapy is needed the patient at first will be registered and the randomization will be deferred at the end of treatment.
In presence of symptoms or signs detected during the clinical visit which may suppose a recurrence or in presence of abnormal tests, the clinician has to prescribe all medical tests and examinations required. The tests carried out in addition to follow-up scheduled program must be reported in the database. Nevertheless patients continue to be followed for the assessment of the performance status at 5 years, but the follow-up schedule is up to the clinician. An interim analysis is scheduled in 3.5 years starting from the beginning of recruitment (based on approximately 1 / 3 of the total expected events, when about 4 / 5 cases have already been enrolled). Patients will be stratified by recruitment Center, by level of risk (calculated according to the stage of the disease, the histotype and the grading) and by type of treatment performed.
The focus of the study is to:
Compare the effect of two FU regimens on 5-years OS
Evaluate the difference in diagnosis anticipation
Evaluate the difference in terms of recurrences
Describe the compliance and QoL of patients
Evaluate the cost-effectiveness and the cost-utility
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
endometrial cancer, follow up, relapse
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1884 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive follow up
Arm Type
Experimental
Arm Description
Intensive follow up in low-risk patients Intensive follow up in high-risk patients
Arm Title
Minimalist follow up
Arm Type
Experimental
Arm Description
Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients
Intervention Type
Procedure
Intervention Name(s)
Intensive/Low-Risk follow up (IA G1; IA G2)
Intervention Description
- 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
Intervention Type
Procedure
Intervention Name(s)
Intensive/High-Risk follow up (≥ IA G3)
Intervention Description
- 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
Intervention Type
Procedure
Intervention Name(s)
Minimalist/Low-Risk follow up (IA G1; IA G2)
Intervention Description
- First 5 years of FU since the end of primary treatment: clinical visit* every 6 months.
* clinical visit with gynecological exploration
Intervention Type
Procedure
Intervention Name(s)
Minimalist/High-Risk follow up (≥ IA G3)
Intervention Description
- 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
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Seven years
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Seven years
Title
Proportion of complications, second cancers, co-morbidity
Time Frame
Seven years
Title
Proportion of asymptomatic patients with diagnosis of relapse
Time Frame
Seven years
Title
Proportion of subjects who complete the two different regimes follow up
Time Frame
Seven years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Zola, MD
Organizational Affiliation
Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Turin
ZIP/Postal Code
10100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19407561
Citation
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.
Results Reference
background
PubMed Identifier
19407551
Citation
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.
Results Reference
background
PubMed Identifier
17868785
Citation
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.
Results Reference
background
PubMed Identifier
17466042
Citation
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.
Results Reference
background
PubMed Identifier
17291227
Citation
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.
Results Reference
background
PubMed Identifier
35858170
Citation
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.
Results Reference
derived
Links:
URL
http://www.epiclin.it
Description
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
Learn more about this trial
Trial Between Two Follow up Regimens With Different Test Intensity in Endometrial Cancer Treated Patients
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