A Randomized, Open Label, Single Centre Clinical Trial of Pelvic External Radiotherapy Combined With 252-Cf Neutron Intracavitary Brachytherapy With or Without Platinum in Treatment of Local Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Long-trem toxicity events
研究概览
简要总结
The objective of this study was to evaluate the efficacy and complication of the treatment of pelvic external combined with 252-Cf neutron intracavitary radiotherapy with or without platinum in local advanced cervical cancer patients in the short and long term.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be aged from 18 (including 18) to 65 (including 65), female patient;
- •Expected survival ≥6 months
- •Pathologically proven diagnosis of squamous carcinoma or adenocarcinoma of the cervix, according to FIGO(International Federation of Gynecology and Obstetrics) staging, appropriate stage for protocol entry, including IIA2, IIB,IIIA,IIIB;
- •No patients with distant metastases;
- •Measurable target lesions (satisfying the criteria in RECIST 1.1);
- •ECOG PS status of 0-2;
- •No prior treatment;
- •Major organ function has to meet the following criteria:
- •Bilirubin <1.5 times the upper limit of normal (ULN)
- •ALT , AST and APL≤2.5 × ULN
- •NEUT≥2.0 × 10^9 / L
- •PLT ≥ 100 × 10^9 / L
- •Serum Cr and urea nitrogen ≤ 1.5 × ULN
- •Favorable cardiac functions, no patients with myocardial infarction within half a year, hypertension and coronary disease are well-controlled.
排除标准
- •Serious heart disease, pulmonary disease, hepatic disease, , renal disease and metabolic disease, or with electrolyte disturbance;
- •Allergic to platinum;
- •Rejecte to join the study in other conditions.
研究组 & 干预措施
Concurrent radiochemotherapy Group
Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
干预措施: Nedaplatin (Drug)
Concurrent radiochemotherapy Group
Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
干预措施: Pelvic External Radiotherapy (Radiation)
Concurrent radiochemotherapy Group
Concurrent radiochemotherapy with Nedaplatin Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f with 8mv-X rays (SSD) 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations; Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
干预措施: 252-Cf Neutron Intracavitary Brachytherapy (Radiation)
Radiotherapy Group
patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations.
干预措施: Pelvic External Radiotherapy (Radiation)
Radiotherapy Group
patients received Radiotherapy only Pelvic External Radiotherapy: patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X Linear Accelerator SSD 252-Cf Neutron Intracavitary Brachytherapy: total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations.
干预措施: 252-Cf Neutron Intracavitary Brachytherapy (Radiation)
结局指标
主要结局
Long-trem toxicity events
时间窗: through study completion, an average of 5 year
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
Acute toxicity events
时间窗: Week 5 of Radiation Therapy (RT)
chemo-related toxicity as measured by CTCAE v. 4.0, radiation-related toxicity as measured by RTOG/EORTC criteria
次要结局
- Disease-free survival (DFS)(through study completion, an average of 3 year)
- 5 Years Overall survial Rate(5 years)
- 2 Years Overall survial Rate(2 years)
- Overall survial (OS)(through study completion, an average of 5 year)
- 3 Years Overall survial Rate(3 years)
研究者
Xin Lei, M.D.Prof
M.D, Prof.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University