Endometrial CancerTOTEMNCT00916708

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

A study testing Intensive/Low-Risk follow up (IA G1; IA G2), Intensive/High-Risk follow up (≥ IA G3) and Minimalist/Low-Risk follow up (IA G1; IA G2) in people with Endometrial Cancer, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Endometrial Cancer
What is being tested?: Intensive/Low-Risk follow up (IA G1; IA G2), Intensive/High-Risk follow up (≥ IA G3) and Minimalist/Low-Risk follow up (IA G1; IA G2)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,884 participants
Where: 1 siteItaly
Study dates: Sep 2008to Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, 10100

Other trials in Italy

About this study

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.

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.

Read the 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

Conditions: Endometrial Cancer
Being tested: 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)
Keywords: endometrial cancer, follow up, relapse
Medical subject headings: Endometrial Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive/Low-Risk follow up (IA G1; IA G2)Procedure or surgery
- 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/High-Risk follow up (≥ IA G3)Procedure or surgery
- 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
Minimalist/Low-Risk follow up (IA G1; IA G2)Procedure or surgery
- First 5 years of FU since the end of primary treatment: clinical visit* every 6 months.
- clinical visit with gynecological exploration
Minimalist/High-Risk follow up (≥ IA G3)Procedure or surgery
- 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

Study groups in NCT00916708
Study group	Role	What they receive
Intensive follow up	Experimental	Intensive follow up in low-risk patients Intensive follow up in high-risk patients Receives: 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 Receives: Procedure: Minimalist/Low-Risk follow up (IA G1; IA G2); Procedure: Minimalist/High-Risk follow up (≥ IA G3)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall survival
Measured: Seven years

Secondary outcomes (4)

Progression-free survival
Measured: Seven years
Proportion of complications, second cancers, co-morbidity
Measured: Seven years
Proportion of asymptomatic patients with diagnosis of relapse
Measured: Seven years
Proportion of subjects who complete the two different regimes follow up
Measured: Seven years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Dec 2020

First posted9 Jun 2009 (estimated)
Study startSep 2008
Primary completion31 Jul 2018 (estimated)
Study completionDec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Endometrial CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,884 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00916708
Sponsor's protocol ID: TOTEM
Acronym: TOTEM
Status last verified: Aug 2018
First submitted: 8 Jun 2009
Last updated: 2 Aug 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 19407561
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.
PubMed 19407551
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.
PubMed 17868785
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.
PubMed 17466042
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.
PubMed 17291227
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.
PubMed 38309033
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.
PubMed 35858170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Endometrial Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00916708
Acronym / sponsor ID: TOTEM / TOTEM
Conditions: Endometrial Cancer
Keywords: endometrial cancer, follow up, relapse
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,884 participants (actual)
Lead sponsor: Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
Collaborators: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Rete Oncologica Piemonte, Valle d'Aosta
Study start: Sep 2008
Primary completion: 31 Jul 2018 (estimated)
Study completion: Dec 2020 (estimated)
First posted: 9 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intensive follow up	Experimental	Procedure: Intensive/Low-Risk follow up (IA G1; IA G2), Procedure: Intensive/High-Risk follow up (≥ IA G3)Intensive follow up in low-risk patients Intensive follow up in high-risk patients
Minimalist follow up	Experimental	Procedure: Minimalist/Low-Risk follow up (IA G1; IA G2), Procedure: Minimalist/High-Risk follow up (≥ IA G3)Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intensive/Low-Risk follow up (IA G1; IA G2)- 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	Procedure or surgery	Intensive follow up
Intensive/High-Risk follow up (≥ IA G3)- 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	Procedure or surgery	Intensive follow up
Minimalist/Low-Risk follow up (IA G1; IA G2)- First 5 years of FU since the end of primary treatment: clinical visit* every 6 months. * clinical visit with gynecological exploration	Procedure or surgery	Minimalist follow up
Minimalist/High-Risk follow up (≥ IA G3)- 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	Procedure or surgery	Minimalist follow up

Primary outcome

Overall survival
Time frame: Seven years

4 secondary outcomes

Progression-free survival
Time frame: Seven years
Proportion of complications, second cancers, co-morbidity
Time frame: Seven years
Proportion of asymptomatic patients with diagnosis of relapse
Time frame: Seven years
Proportion of subjects who complete the two different regimes follow up
Time frame: Seven years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
Background: PubMed 19407561Gadducci 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.
Background: PubMed 19407551Zanagnolo 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.
Background: PubMed 17868785Zola 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.
Background: PubMed 17466042Zola 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.
Background: PubMed 17291227Gadducci 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.
Derived from this study: PubMed 38309033Rosato 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.
Derived from this study: PubMed 35858170Zola 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.
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 appointmentLink provided by the sponsor.
Individual participant dataSharing planned: No

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Active, not recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paolo Zola, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Seven years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00916708, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.