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

August 1, 2018 updated by: Paolo Zola, Azienda Ospedaliera San Giovanni Battista

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:

  1. Minimalist (Arm 1)
  2. Intensive (Arm 2)

Features of each arm are listed in "Arms" item.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1884

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10100
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive follow up
Intensive follow up in low-risk patients Intensive follow up in high-risk patients
Procedure: 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: 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
Experimental: Minimalist follow up
Minimalist follow up in low-risk patients Minimalist follow up in high-risk patients
Procedure: 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Seven years
Seven years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Giovanni Battista

Collaborators

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Rete Oncologica Piemonte, Valle d'Aosta

Investigators

  • Principal Investigator: Paolo Zola, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

July 31, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ToTEM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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