Chemotherapy Versus Chemoradiotherapy on the Prognosis for Postoperative Endometrial Cancer With P53-mutation Profile: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 294
- 主要终点
- the 2-year progression-free survival(PFS)
研究概览
简要总结
Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.
详细描述
According to tumor molecular characteristic, endometrial cancer can be divided into four types with different biological behaviors and prognosis: POLE hypermutation （POLEmut）, Mismatch repair system defect (MMRd), Non special molecular feature (NSMP) and P53 mutation (p53mut) For the postoperative therapy, preliminary data showed that p53mut endometrial cancer was more sensitive to chemotherapy. Therefore, we propose a hypothesis: for p53mut endometrial carcinoma, compared with chemoradiotherapy, postoperative chemotherapy alone had similar effects on the prognosis and similar treatment-related adverse reactions, but could avoid radiotherapy-related adverse effects and reduce medical expenses. And more high-quality evidence is needed to prove the hypothesis.
This study were approved by the Fudan University Shanghai Cancer Center and all other institutes. Before initiation of study procedures, written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose.
Patients will be stratified into 4 layers by surgical pathological staging (FIGO 2009), preoperative and postoperative imaging evaluation, surgical conditions and postoperative pathology : stage IA,stage IB-II, stage III-IVA ( no residual lesion after operation), any stage with maximum diameter of residual lesion <2cm (except stage IVB). After stratification, Eligible patients in each stratification of each center will be randomly assigned (1:1) to receive:
Arm1:Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks, a total of 6 course.
Arm2: Stage IA: TC regimen for 4 course+VBT. Stage IB-IVA (no residual lesion after operation) and any stage with maximum diameter of residual lesion <2cm (except stage IVB): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course (same as above) ±VBT.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years,
- •Patients with stage I-IVA (FIGO2009) (excluded endometrial epithelial carcinoma confined to the endometrial layer), which have received initial diagnosis and comprehensive staging surgery (based on total uterine and double salpingectomy. Lymph nodes are evaluated by at least a sentinel lymph node biopsy), regardless of the pathological type, at the same time, the molecular typing of preoperative endometrial biopsy or total hysterectomy should be type p53mut.
- •The duration of postoperative adjuvant therapy after initiation shall not exceed 8 weeks after enrollment,
- •There is no obvious abnormality in the function of important organs, and the relevant test values meet the following requirements:
- •A. White blood cell count ≥3×109/L or absolute value of neutrophile granulocyte ≥ 1.5×109/L,
- •B. Platelet count ≥ 100× 109/L,
- •C. AST and/or ALT<2.5 times the upper limit of normal value,
- •D. Serum creatinine < 2 times the upper limit of normal value,
- •E. Physical fitness score: Karnofsky(KPS) score ≥60, The Eastern Cooperative Oncology Group(ECOG) score is ≤2 points.
排除标准
- •Tumors from uterine stroma,
- •Recurrent endometrial malignant tumor,
- •Those who have received other anti-tumor treatments within half a year before surgery: including neoadjuvant chemotherapy, hormone therapy, target therapy, immunotherapy, and biological therapy,etc.
- •Those in pregnancy and perinatal period,
- •Concurrent with other malignant tumors of reproductive system or non-reproductive system,
- •History of important organ transplantation,
- •Those who need to take immunosuppressants with a history of immune diseases,
- •History of severe mental illness and brain dysfunction,
- •History of drug abuse or drug use,
- •Participants in other clinical trials at the same time,
- •Those who are unable or unwilling to receive postoperative adjuvant chemotherapy or radio-chemotherapy/sign the informed consent form/comply with the research requirements,
- •Patients of any stage who are excluded or unable to tolerate radiotherapy and chemotherapy after evaluation without indication of radiotherapy.
研究组 & 干预措施
Arm1: Chemotherapy group
Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks with total of 6 cycles.
干预措施: Paclitaxel (Drug)
Arm1: Chemotherapy group
Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks with total of 6 cycles.
干预措施: Carboplatin (Drug)
Arm2: Radiotherapy plus chemotherapy group
Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.
Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease <2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
干预措施: Paclitaxel (Drug)
Arm2: Radiotherapy plus chemotherapy group
Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.
Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease <2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
干预措施: VBT (Radiation)
Arm2: Radiotherapy plus chemotherapy group
Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.
Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease <2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
干预措施: Carboplatin (Drug)
Arm2: Radiotherapy plus chemotherapy group
Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.
Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease <2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
干预措施: Cisplatin (Drug)
Arm2: Radiotherapy plus chemotherapy group
Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.
Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease <2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.
Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.
干预措施: EBRT (Radiation)
结局指标
主要结局
the 2-year progression-free survival(PFS)
时间窗: 2 years
The percentage of patients who have first relapse within 2 years after surgery.
次要结局
- the 3-year PFS(3 years)
- the 5-year PFS and Overall survival(OS)(5 years)