Studio TOTEM

Appropriateness evaluation of followup procedures in Gynaecology Oncology. A multicentric randomized controlled clinical trial between two followup regimens with different tests intensity in endometrial cancer treated patients.

Study design and objectives in brief

The term followup, in Oncology, refers to a group of pre-scheduled medical tests and procedures set to identify all disease relapses at a pre-clinical stage. This concept of long-term monitoring assumes that an early diagnosis may reduce patient's morbidity and mortality.

The systematic controls schedule for the clinician has the aim to evaluate overall survival, disease control and performance status of the patient, to manage treatment complications and to detect early relapses. At the same time the interest of the physician is focused on finding optimal time interval between controls, more effective diagnostic tests and most suitable programme of followup for each patient.

In endometrial cancer the procedures adopted in different followup policies, especially the frequency of their applications, remain strongly variable and comprise two main types of regimens: the first could be defined as minimalist (clinical examination associated with rare medical tests) and the second as intensive (clinical examination, imaging and markers). Nowadays there are no available data supported by an adequate level of evidence that a intensive programme of followup has a better impact on survival rate compared to a minimalist programme.

Primary objective

Our study has the goal to understand if there is any statistically difference between the two regimens in terms of 5-years overall survival.

Secondary objectives

  • Quantify the intensive program possibility to advance the diagnosis comparing to minimalist program
  • Evaluate the difference in terms of complications, recurrences of disease, second primary tumors and maybe other diseases.
  • Assessing the accuracy of the two schemes of followup as the ability to diagnose the relapse of disease in asymptomatic patients.
  • Describe the compliance to different followup programs.
  • Formally evaluate quality of life and patients satisfaction about the two strategies of followup.
  • Formally evaluate the cost-effectiveness and the cost-utility of the two regimens.


Promoting committee

  • Giovanni Apolone – Istituto Mario Negri, Milano (MI)
  • Giovannino CicconeCPO Piemonte, Torino (TO)
  • Libero CiuffredaAOU Città della Salute e della Scienza di Torino - PO Molinette, Torino (TO)
  • Roberto Faggiuolo – SOC Oncologia Presidio Ospedaliero, Alba-Bra (CN)
  • Angiolo Gadducci – Azienda Ospedaliero-Universitaria Pisana, Pisa (PI)
  • Luciano Galletto – Ospedale E. Agnelli, Pinerolo (TO)
  • Fabio Landoni – Istituto Europeo di Oncologia, Milano (MI)
  • Tiziano Maggino – Ospedale "Umberto I", Venezia-Mestre (VE)
  • Paola Mosconi – Istituto Mario Negri, Milano (MI)
  • Franca Ozzello – Ospedale Civile, Ivrea (TO)
  • Enrico Sartori – Spedali Civili, Brescia (BS)
  • Carlo SenoreCPO Piemonte, Torino (TO)
  • Alessandro Urgesi - OIRM/Sant'Anna, Torino (TO)
  • Paolo Zola – Dipartimento Discipline Ostetriche Ginecologiche Università degli Studi di Torino (Coordinatore), Torino (TO)

Scientific committee

  • Annamaria Ferrero - Ospedale Mauriziano Umberto I, Torino (TO)
  • Simona Mazzola - Ospedale Mauriziano Umberto I, Torino (TO)

Coordinating Center

  • Manuela Ceccarelli
    CPO Piemonte, Torino (TO)
  • Roldano Fossati
    Istituto Mario Negri, Milano
  • Luca Fuso
    Ospedale Mauriziano Umberto I, Torino (TO)
  • Stefania Perotto
    Ospedale Mauriziano Umberto I, Torino (TO)
  • Elisa Piovano
    Presidio Ospedaliero Martini - ASL TO1, Torino (TO)
  • Fabio Saccona
    CPO Piemonte, Torino (TO)
  • Annalisa Rossi
    Ospedale Mauriziano Umberto I, Torino (TO)

Indipendent Committee of data monitoring

Istituto Mario Negri, Milano (MI)