Groningen International Study on Sentinel Nodes in Vulvar Cancer-III, a Prospective Phase II Treatment Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 157
- 试验地点
- 27
- 主要终点
- Groin recurrence rate
研究概览
简要总结
Vulvar cancer patients with SN-metastasis > 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
详细描述
Rationale:
Standard treatment of early stage vulvar cancer is a wide local excision of the primary tumor combined with the sentinel node (SN) procedure for the groins. An inguinofemoral lymphadenectomy (IFL) is only indicated in case of a positive SN. An IFL is associated with major morbidity, e.g. wound healing problems, lymphoceles, lymphedema of the legs and recurrent infections. GROINSS-V II investigated whether radiotherapy would be a safe alternative for IFL in case of SN metastasis. The results for radiotherapy in the group with metastasis ≤ 2mm are promising. This study also showed that for metastasis > 2mm, only radiotherapy was not efficient. The efficacy of treatment can be increased by adding chemotherapy or giving a higher dose of radiotherapy. GROINSS-V III will investigate this regimen.
Objective:
The primary objective of this study is to investigate the safety of replacing inguinofemoral lymphadenectomy by chemoradiation in early stage vulvar cancer patients with a macrometastasis (>2mm) and/or extracapsular extension in the SN. The secondary objective is to evaluate the short and long-term morbidity associated with the SN procedure and chemoradiation.
Study design: Phase II treatment trial, with stopping rules for the incidence of groin recurrences.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological confirmed primary SCC of the vulva
- •T1 tumor, not encroaching urethra/vagina/anus
- •Depth of invasion > 1mm
- •Tumor diameter < 4cm
- •Unifocal tumor
- •No enlarged (>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
- •Possibility to obtain informed consent
- •Metastatic sentinel lymph node; size of metastasis > 2mm and / or extracapsular extension, or
- •Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm
- •Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
- •Adequate bone marrow, renal and liver function:
- •Absolute neutrophil count ≥ 1.5 x 109 /L
- •Platelet count ≥ 100 x 109 /L
- •Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula
- •Total bilirubin < 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN
- •Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Appendix A)
- •Age 18 years or older
- •Life expectancy of ≥ 12 weeks
- •Written informed consent
排除标准
- •Inoperable tumors and tumors > 4cm
- •Multifocal tumors
- •Tumors with other pathology than squamous cell carcinoma
- •Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
- •No other carcinomas, other than basal cell carcinomas, within last 5 years
- •History of pelvic radiotherapy
- •History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
- •Pregnant female or nursing mother
- •Desire to become pregnant
- •Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- •Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment
研究组 & 干预措施
Chemoradiation
Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29
干预措施: Radiotherapy combined with cisplatin (Radiation)
Chemoradiation
Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29
干预措施: Cisplatin (Drug)
结局指标
主要结局
Groin recurrence rate
时间窗: Within first 2 years after primary treatment
Groin recurrence in the groin with SN metastasis treated with chemoradiation
次要结局
- Treatment related morbidity(First two years after primary treatment)
- Quality of life as assessed using EORTC-QLQc30(First two year after primary treatment)
- Quality of life-vulvar cancer specific, as assessed using VU34(First two year after primary treatment)
研究者
Maaike Oonk
Principle Investigator
University Medical Center Groningen