Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.
详细描述
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.
In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 Years to 70 Years，female
- •Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
- •no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
- •Moderate or high expression of EGFR
- •The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
- •WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L
- •ALT, AST and Cr below 1.5 times of normal level
- •Willing to accept treatment
- •Ability to comply with trial requirements KPS≥70
排除标准
- •Evidence of distance metastasis
- •Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm)
- •Couldn't examine with pelvic MRI due to a variety of reasons
- •Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
- •Diagnosed with another malignant tumor in 5 years
- •Used to be a volunteer of other clinical trial.
- •Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs
- •Severe medical history of lung ,liver, kidney or heart.
- •Active infection in any part of the whole body.
- •Examination results showed radiotherapy contraindications
研究组 & 干预措施
control group
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: Cisplatin (Drug)
control group
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: External Beam Radiation Therapy (Radiation)
control group
Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy.
干预措施: Internal Radiation Therapy (Radiation)
experimental group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
干预措施: Cisplatin (Drug)
experimental group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
干预措施: External Beam Radiation Therapy (Radiation)
experimental group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
干预措施: Internal Radiation Therapy (Radiation)
experimental group
Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
干预措施: nimotuzumab (Drug)
结局指标
主要结局
Overall survival rate
时间窗: at 3 years
Described with Kaplan-Meier curves and unadjusted logrank tests.
non-distant metastasis survival rate
时间窗: at 3 years
survival period of non-progressive.
时间窗: at 3 years
disease free survival rate
时间窗: at 3 years
次要结局
- Radiation protocol compliance(3 years)
- Rate of acute and long-term toxicities(3 years)
- Quality of life(3 years)
研究者
Mei Shi
Director and professor of Radiation Oncology，Xijing Hospital，Fourth Millitary Medical University
Air Force Military Medical University, China