A Randomised Trial of Non-selective Versus Selective Adjuvant Therapy in High Risk Apparent Stage 1 Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The primary aim of this trial is to determine whether lymphadenectomy, used to restrict adjuvant therapy (other than vaginal brachytherapy) to node positive women, results in a non-inferior survival as compared to adjuvant therapy given to all women with high risk apparent stage 1 endometrial cancer.
详细描述
Results from this trial have the potential to change practice whatever the results: either lymphadenectomy will become recommended practice if a non-inferior outcome is obtained; otherwise the procedure can be safely abandoned.
Secondary Objectives
- Disease-free, endometrial cancer-event free and endometrial cancer-specific survival
- Distribution of pelvic and extra-pelvic relapse
- Cost effectiveness
- Surgical adverse events
There are also two sub-studies:
- Quality of life - all patients i. Describe the trajectory of key patient reported outcomes (PROs) from baseline up to 5 years post-surgery ii. Compare the specific PRO domains between the trial arms at several specific time points iii. Determine the proportion of women in each trial arm reporting long-term symptoms after treatment as measured by the symptom-specific subscales of the measures (gastrointestinal symptoms, urological symptoms, attitude to disease and treatment, vaginal symptoms, lymphoedema) iv. Determine the correlation between physician rating (CTCAE v4.03) and patient-report (corresponding PRO subscale) for various symptoms reported by both physicians and patients v. Assess the correlation between self-assessed lymphoedema (Self-report lower-extremity lymphoedema screening questionnaire) and the lymphoedema subscale of the Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed high risk apparent International Federation of Gynecology and Obstetrics (FIGO) stage I endometrial cancer according to one of the following criteria. Confirmation must be based on either diagnostic endometrial sampling or hysterectomy and BSO specimen if randomisation occurring after hysterectomy and BSO:
- •FIGO grade 3 endometrioid or mucinous carcinoma
- •High grade serous, clear cell, undifferentiated or dedifferentiated carcinoma or mixed cell adenocarcinoma or carcinosarcoma
- •Surgery to be performed ≤ 5 weeks after randomisation in patients randomised prior to hysterectomy and BSO. Patients randomised after hysterectomy and BSO must have undergone hysterectomy and BSO ≤ 28 days prior to randomisation. Patients randomised after hysterectomy and BSO who are allocated lymphadenectomy must undergo lymphadenectomy ≤ 5 weeks after randomisation
- •Written informed consent
- •No prior anticancer therapy for endometrial cancer
- •Eastern Cooperative Oncology Group (EGOC) performance status 0-2
- •Life expectancy > 3 months
- •Age ≥ 16 years
- •Adequate organ and bone marrow function
- •Ability to undergo post-operative chemotherapy with or without radiotherapy
- •Adjuvant treatment to commence ≤ 8 weeks after surgery
- •Willingness and ability to complete Quality of Life questionnaires
排除标准
- •Grossly enlarged node(s) of ≥ 10 mm short axis on baseline radiological imaging
- •Invasion of the cervical stroma on baseline radiological imaging or obvious cervical disease on clinical examination
- •Involvement of uterine serosa or metastatic disease seen outside the uterus on baseline radiological imaging
- •Small cell carcinoma with neuroendocrine differentiation
- •Concurrent anti-cancer therapy
- •Previous malignancy < 5 years prior to randomisation or concurrent malignant disease with the exception of:
- •carcinoma in situ of cervix
- •non-melanoma skin cancer
- •basal cell carcinoma
- •melanoma in situ
- •Women who are pregnant or lactating
研究组 & 干预措施
Abdominal surgery with lymphadenectomy
Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)* with lymph node dissection to determine whether lymph nodes are positive or negative:
Positive: patients will receive systemic adjuvant treatment to include chemotherapy Negative: patients will receive vaginal brachytherapy only
Patients will then be followed up, to include assessment of adverse events and quality of life.
*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, the lymph node dissection will be performed as a separate procedure.
干预措施: Abdominal surgery (Procedure)
Abdominal surgery with lymphadenectomy
Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)* with lymph node dissection to determine whether lymph nodes are positive or negative:
Positive: patients will receive systemic adjuvant treatment to include chemotherapy Negative: patients will receive vaginal brachytherapy only
Patients will then be followed up, to include assessment of adverse events and quality of life.
*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, the lymph node dissection will be performed as a separate procedure.
干预措施: Lymphadenectomy (Procedure)
Abdominal surgery, no lymphadenectomy
Patients will receive a hysterectomy and bilateral salpingo-oophorectomy (BSO)*. Patients will receive systemic adjuvant treatment to include chemotherapy.
Patients will then be followed up, to include assessment of adverse events and quality of life.
*There is an option for patients to be randomised following a pre-trial hysterectomy and BSO. If randomised to this arm, no further surgery will be given and the patient will proceed to receive systemic adjuvant treatment to include chemotherapy.
干预措施: Abdominal surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: 5 years
Overall survival
次要结局
- Disease-free survival(5 years)
- Endometrial cancer-event free survival(5 years)
- Surgical adverse events(5 years)
- Cost effectiveness(5 years)
- Endometrial cancer-specific survival(5 years)
- Pelvic and extra-pelvic relapse-free survival(5 years)