Hypofractionated Radiotherapy in Cervical Cancer: A Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 396
- 试验地点
- 1
研究概览
简要总结
This is a prospective non inferiority randomized controlled trial in locally advanced carcinoma cervix stages IB3 to IIIC1 comparing standard fractionated chemoradiation with a hypofractionated chemoradiation regimen. Patients are randomized by computer generated block randomization into two arms of 198 each to receive either IMRT 45 Gy in 25 fractions over 5 weeks with weekly cisplatin and nodal SIB boost to 55 Gy followed by image guided HDR brachytherapy, or IMRT 37.5 Gy in 15 fractions over 3 weeks with weekly cisplatin and nodal boost to 48 Gy followed by the same brachytherapy schedule. The primary outcome is pelvic loco regional recurrence at 3 months post treatment, and secondary outcomes include acute and late toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy.
- •Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology.
- •Patients with stage stage IB3 to IIIB and IIIC1, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-
- •Signed informed consent.
- •Adequate end organ function hepatic, renal, cardiac reserve.
排除标准
- •Patients with stage IIIC2, IVA, or IVB Patients with prior malignancies or active autoimmune diseases will be excluded from the study.
- •Other histology melanoma, small cell, basal cell carcinoma Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment.
- •Contraindications to CEMRI, brachytherapy Age less than 18 years.
- •Uncontrolled medical comorbidity.
研究者
DR KARUN KAMBOJ
AIIMS New Delhi