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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,884
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
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:
- Minimalist (Arm 1)
- Intensive (Arm 2)
Features of each arm are listed in "Arms" item.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall survival
时间窗: Seven years
次要结局
- Proportion of subjects who complete the two different regimes follow up(Seven years)
- Proportion of complications, second cancers, co-morbidity(Seven years)
- Progression-free survival(Seven years)
- Proportion of asymptomatic patients with diagnosis of relapse(Seven years)
研究者
Paolo Zola
Paolo Zola MD, Study Coordinator
A.O.U. Città della Salute e della Scienza