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

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ClinicalTrials.gov Identifier: NCT00916708
Recruitment Status : Unknown
Verified August 2018 by Paolo Zola, Azienda Ospedaliera Città della Salute e della Scienza di Torino.
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2009
Last Update Posted : August 2, 2018
Sponsor:
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

Study Description
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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:

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

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


Condition or disease Intervention/treatment Phase
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) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1884 participants
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.
Study Start Date : September 2008
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : December 2020
Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Seven years ]
  2. Proportion of complications, second cancers, co-morbidity [ Time Frame: Seven years ]
  3. Proportion of asymptomatic patients with diagnosis of relapse [ Time Frame: Seven years ]
  4. Proportion of subjects who complete the two different regimes follow up [ Time Frame: Seven years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Italy, 10100
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
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Principal Investigator: Paolo Zola, MD Azienda Ospedaliera Città della Salute e della Scienza di Torino - University of Turin
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paolo Zola, Paolo Zola MD, Study Coordinator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT00916708    
Other Study ID Numbers: TOTEM
First Posted: June 9, 2009    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
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:
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Endometrial Neoplasms
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