Neo-Adjuvant Chemotherapy and Conservative Surgery in Cervical Cancer to Preserve Fertility
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- efficacy of neo-adjuvant chemotherapy
研究概览
简要总结
If no metastases are observed, patients will start a short protocol of four courses of weekly neo-adjuvant chemotherapy (12 weeks). If response to chemotherapy results in a tumor of less than 2 cm, cervical conisation will be performed.
详细描述
The standard treatment of stage Ib1 2-4 cm cervical cancer in women who wish to preserve fertility is an abdominal radical trachelectomy with pelvic lymph node dissection. Since the number of take home babies after completing this procedure is below 10%, there is a need for exploration of alternative treatment modalities with better chances of preserving fertility at equal risk of recurrence. Since low fertility rates after abdominal radical hysterectomy are observed due to the radical surgery performed on the uterine cervix, less radical surgery is warranted. To enable less radical surgery by cervical conisation, neo-adjuvant chemotherapy to reduce tumor size is incorporated to the multi-modal treatment scheme of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage Ib1 cervical cancer measuring ≥2 - ≤4 cm on physical examination and imaging in any direction
- •Histologic type: squamous cell carcinoma (SCC), adeno cell carcinoma (ACC), adeno-squamous cell carcinoma (ASC)
- •Lymph vascular space invasion allowed (LVSI)
- •Age ≥18 years and ≤ 40 years
- •Wish to preserve fertility
- •Written and signed informed consent
- •Negative serum or urine pregnancy test within 14 days prior to registration, and an effective method of contraception must be used during treatment
- •MRI abdomen and pelvis, chest X-ray must be performed and negative for metastatic disease within 12 weeks of enrolment
- •No metastases on pelvic lymph node dissection
- •Laboratory values: serum creatinine < 140 μmol/L; creatinine clearance > 60 ml/min(Cockroft formula); white blood cell count > 3.5 x 109/l; platelets > 100 x 109 /l
排除标准
- •Other high grade histologies like neuro-endocrine and clearcell carcinoma
- •FIGO stage Ia, Ib1< 2 cm, Ib2, II, III and IV disease
- •Involvement of tumor in uterine corpus on MRI or hysteroscopy if performed
- •Evidence of metastatic disease on imagining (PET/CT/MRI) performed within 12 weeks of enrolment
- •other malignancy
研究组 & 干预措施
neo-adjuvant chemotherapy
The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to <2 cm
干预措施: Paclitaxel (Drug)
neo-adjuvant chemotherapy
The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to <2 cm
干预措施: Carboplatin (Drug)
neo-adjuvant chemotherapy
The patients are given weekly paclitaxel 80 mg/m2 + carboplatin AUC=2 (or AUC=6 per three weeks) during 12 weeks/4 courses followed by conization if tumor size is reduced to <2 cm
干预措施: conisation (Procedure)
结局指标
主要结局
efficacy of neo-adjuvant chemotherapy
时间窗: week 6 of neoadjuvant treatment
efficacy of neo-adjuvant chemotherapy on tumor response
safety of neo-adjuvant chemotherapy
时间窗: 2 years after conisation
defined as number of women who get recurrence within two years after conisation
次要结局
- fertility(5 years after treatment)
- ovarian function(2 years after conisation)