Primary Chemoradiation VS. Neoadjuvant Chemotherapy Followed By Surgery As Treatment Strategy For Locally Advanced Vulvar Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Loco-regional control after 24 months per completed treatment including salvage treatment
研究概览
简要总结
A phase 2 randomised controlled trial will be performed in which the efficacy and safety of standard treatment (primary chemoradiation; consisting of 64.5 Gy in 30 fractions of external beam radiotherapy with weekly cisplatin for six weeks) and experimental treatment (NACT; consisting of carboplatin and paclitaxel in a 3-weekly scheme) will be compared in 98 patients with LAVC, registered from eight national medical centres.
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
- •Woman ≥ 18 years
- •Signed and written informed consent.
- •Histologically-confirmed primary or recurrent squamous cell carcinoma vulvar cancer FIGO stage Ib - IVa, T1b or higher, any N, M
- •Local tumour through which the size or localization implies requirement of treatment through primary chemoradiation or surgery consisting of extensive surgery (meaning surgery damaging pelvic organs or exenterative surgery). This can imply;
- •T1b or larger tumour with (irresectable) groin metastases
- •T1b or larger tumour with a close relationship to and/or involvement of the urethra or anal sphincter
- •World Health Organization performance status of 0-2
- •Adequate haematological function defined by platelet count >100x10E9/L, absolute leukocyte >3X10E9/L or neutrophil count (ANC) >1.5x10E9/L, and hemoglobin >6.0 mmol/L
- •Adequate hepatic function defined by a total bilirubin level ≤1.5x the upper limit of normal (ULN) range and ASAT and ALAT levels ≤2.5x ULN for all subjects
- •Adequate renal function defined by an estimated creatinine clearance ≥50mL/min according to the Cockroft-Gault formula (or local institutional standard method)
- •Beta HCG level of 14 mIU/mL or below for women of childbearing potential
- •Highly effective contraception for patients if the risk of conception exists
排除标准
- •Patients with highly suspicious or positive metastases to the pelvic lymph nodes
- •* Patients eligible for radical local excision without involvement of other organs
- •Any psychiatric condition that would prohibit the understanding or rendering of informed consent
- •Prior radiotherapy to the pelvis or groin area limiting full dose chemoradiation according to protocol
- •Existing neuropathy which will hinder the intake of chemotherapy
研究组 & 干预措施
Primary chemoradiation
Patients included in the standard treatment arm will receive a combination of weekly cisplatin combined with 30 fractions of external beam radiotherapy on the primary tumour with a total dose of 64.5 Gy. Cisplatin will be given for six weeks intravenously with a dose of 40 mg/m2, if possible on the first day of the week. On day 1 until day 5 the patient will receive external beam radiotherapy. This will be repeated for a six-week period.
干预措施: Chemoradiation (Combination Product)
NACT (3-weekly carboplatin and paclitaxel) followed by surgery
Patients included in the experimental arm will be treated with intravenous infusion of paclitaxel 175 mg/m2, followed by carboplatin 5 area under the curve (AUC). This will be administered in a 3-weekly scheme with preferably 3 and a maximum of 4 courses, with evaluation after two courses of chemotherapy by physical examination. NACT will be subsequently followed by radical surgery in responding patients. A four to six weeks interval after the last course of chemotherapy needs to be respected before surgery, to allow sufficient physical recovery.
干预措施: Paclitaxel and Carboplatin (Drug)
结局指标
主要结局
Loco-regional control after 24 months per completed treatment including salvage treatment
时间窗: 24 months after completed treatment
Proportion of patients free from local-regional progression
次要结局
- Disease-related treatment failure(24 months after completed treatment)
- Treatment related death(24 months after completed treatment)
- Functional organ preservation(24 months after completed treatment)
- Disease free survival(24 months after completed treatment)
- Overall survival(24 months after completed treatment)
- Patterns of recurrence of disease(24 months after completed treatment)
- Prevention of trimodal treatment(24 months after completed treatment)
- Short term and long term complications(24 months after completed treatment)