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

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.

Conditions

• Endometrial Cancer

Interventions

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

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

Sponsors & Collaborators

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

  collaborator OTHER

• Rete Oncologica Piemonte, Valle d'Aosta

  collaborator OTHER

• Azienda Ospedaliera San Giovanni Battista

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2018-07-31

Completion

2020-12-31

Countries

• Italy

Study Locations