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

Endometrial Cancer Clinical Trial

— TOTEM  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00916708
• Other study ID #: TOTEM
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2008
• Est. completion date: December 2020

Study information

• Verified date: August 2018
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1884
• Est. completion date: December 2020
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte, Rete Oncologica Piemonte, Valle d'Aosta

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 Apr 26. Review. — View Citation

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. Epub 2007 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Seven years
Secondary	Progression-free survival		Seven years
Secondary	Proportion of complications, second cancers, co-morbidity		Seven years
Secondary	Proportion of asymptomatic patients with diagnosis of relapse		Seven years
Secondary	Proportion of subjects who complete the two different regimes follow up		Seven years

External Links

•   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 appointment