Multicenter Prospective Randomized Study on NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Patients With Cervical Cancer FIGO Stage IB2 and IIB
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 534
- 主要终点
- disease free survival
研究概览
简要总结
Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.
详细描述
The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years
- •cervical cancer FIGO IB2, IIB,
- •squamous cell, adeno or adenosquamous cell carcinoma
- •informed consent
排除标准
- •small cell/neuroendocrine component
- •previous radiation, previous cancer
- •pregnancy
- •severe co-morbidities
研究组 & 干预措施
Arm A: NACT+radical hysterectomy
Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
干预措施: hysterectomy (Procedure)
Arm A: NACT+radical hysterectomy
Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
干预措施: Cisplatin (Drug)
Arm A: NACT+radical hysterectomy
Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
干预措施: Paclitaxel (Drug)
Arm A: NACT+radical hysterectomy
Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
干预措施: Carboplatin (Drug)
Arm A: NACT+radical hysterectomy
Arm A includes patients for dose dense chemotherapy using TP (paclitaxel, carboplatin) or TIP (cisplatin, paclitaxel, ifosfamide) weekly for six cycles. Radical hysterectomy is performed after the 6th week + lymphadenectomy
干预措施: Ifosfamide (Drug)
Arm B: Chemoradiation
Arm B includes patients undergoing primary cisplatin based chemo-radiation
干预措施: Radiation (Radiation)
Arm B: Chemoradiation
Arm B includes patients undergoing primary cisplatin based chemo-radiation
干预措施: Cisplatin (Drug)
结局指标
主要结局
disease free survival
时间窗: 5 years
DFS
次要结局
- overall survival(5 years)
- local control(5 years)
- quality of life(5 years)
研究者
S. Marnitz
Prof. Dr. med. S. Marnitz
Charite University, Berlin, Germany