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.
18 Years
N/A
Female
Endometrial Cancer
Trial Information
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.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
Overall survival
Outcome Time Frame:
Seven years
Safety Issue:
Yes
Principal Investigator
Paolo Zola, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Turin
Authority:
Italy: Ethics Committee
Study ID:
TOTEM
NCT ID:
NCT00916708
Start Date:
September 2008
Completion Date:
August 2015
Related Keywords:
- Endometrial Cancer
- endometrial cancer
- follow up
- relapse
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
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