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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Azienda Ospedaliera San Giovanni Battista
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by:
Azienda Ospedaliera San Giovanni Battista
ClinicalTrials.gov Identifier:
NCT00916708
First received: June 8, 2009
Last updated: June 30, 2011
Last verified: June 2011
  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 Phase
Endometrial Cancer
Procedure: Intensive/Low-Risk Treatment (IA G1; IA G2)
Procedure: Intensive/High-Risk Treatment (≥ IA G3)
Procedure: Minimalist/Low-Risk Treatment (IA G1; IA G2)
Procedure: Minimalist/High-Risk Treatment (≥ IA G3)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Giovanni Battista:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Seven years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Seven years ] [ Designated as safety issue: Yes ]
  • Proportion of complications, second cancers, co-morbidity [ Time Frame: Seven years ] [ Designated as safety issue: Yes ]
  • Proportion of asymptomatic patients with diagnosis of relapse [ Time Frame: Seven years ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who complete the two different regimes follow up [ Time Frame: Seven years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2300
Study Start Date: September 2008
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Procedure: Intensive/Low-Risk Treatment (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 Treatment (≥ 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 Procedure: Minimalist/Low-Risk Treatment (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 Treatment (≥ 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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916708

Contacts
Contact: Paolo Zola +39 011 5082688 paolo.zola@unito.it

Locations
Italy
Department of Gynecology and Obstetrics, University of Turin, Ospedale Mauriziano Umberto I Recruiting
Turin, Italy, 10100
Sponsors and Collaborators
Azienda Ospedaliera San Giovanni Battista
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Investigators
Principal Investigator: Paolo Zola, MD University of Turin
  More Information

Additional Information:
Publications:
Responsible Party: Paolo Zola MD Study Coordinator, Rete Oncologica Piemonte Valle d'Aosta
ClinicalTrials.gov Identifier: NCT00916708     History of Changes
Other Study ID Numbers: TOTEM
Study First Received: June 8, 2009
Last Updated: June 30, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Giovanni Battista:
endometrial cancer
follow up
relapse

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on July 20, 2014