We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified April 2017 by Paolo Zola, Azienda Ospedaliera Città della Salute e della Scienza di Torino
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916708
First Posted: June 9, 2009
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Rete Oncologica Piemonte, Valle d'Aosta
Information provided by (Responsible Party):
Paolo Zola, Azienda Ospedaliera Città della Salute e della Scienza di Torino
  Purpose

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.


Condition Intervention
Endometrial Cancer Procedure: Intensive/Low-Risk follow up (IA G1; IA G2) Procedure: Intensive/High-Risk follow up (≥ IA G3) Procedure: Minimalist/Low-Risk follow up (IA G1; IA G2) Procedure: Minimalist/High-Risk follow up (≥ IA G3)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.

Further study details as provided by Paolo Zola, Azienda Ospedaliera Città della Salute e della Scienza di Torino:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Seven years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2300
Study Start Date: September 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916708


Contacts
Contact: Paolo Zola +39 011 3131523 paolo.zola@unito.it

Locations
Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Turin, Italy, 10100
Contact    +390113131523      
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
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
  More Information

Additional Information:
Publications:
Responsible Party: Paolo Zola, Paolo Zola MD, Study Coordinator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT00916708     History of Changes
Other Study ID Numbers: TOTEM
First Submitted: June 8, 2009
First Posted: June 9, 2009
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paolo Zola, Azienda Ospedaliera Città della Salute e della Scienza di Torino:
endometrial cancer
follow up
relapse

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female