A Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally-Advanced Squamous Cell Carcinoma of the Vulva
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 103
- 主要终点
- Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
研究概览
简要总结
This phase II trial is studying how well giving radiation therapy together with cisplatin followed by surgery works in treating patients with locally advanced cancer of the vulva. Drugs used in chemotherapy such as cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may shrink the tumor so it can be removed during surgery.
详细描述
OBJECTIVES:
I. Determine the efficacy of radiotherapy and cisplatin, in terms of achieving a complete clinical and pathological response, in patients with locally advanced squamous cell carcinoma of the vulva that is not amenable to standard radical vulvectomy.
II. Determine the toxicity of this regimen followed by surgery in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced squamous cell carcinoma of the vulva
- •T3 or T4 (N0-3, M0)
- •Not amenable to surgical resection by standard radical vulvectomy
- •Previously untreated disease
- •No recurrent disease
- •No vulvar melanoma or sarcoma
- •Performance status - GOG 0-3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times normal
- •Alkaline phosphatase no greater than 3 times normal
- •SGOT no greater than 3 times normal
- •Creatinine no greater than 2.0 mg/dL
- •No gastrointestinal bleeding
- •No severe gastrointestinal symptoms
- •Capable of tolerating a radical course of chemoradiotherapy
- •No septicemia
- •No severe infection
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No circumstance that would preclude study completion or follow-up
- •No prior cytotoxic chemotherapy
- •No prior pelvic radiotherapy
- •No concurrent boost brachytherapy
- •No prior anticancer therapy that would contraindicate study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (conventional surgery, radiation therapy, cisplatin)
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.
Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
干预措施: 3-Dimensional Conformal Radiation Therapy (Radiation)
Treatment (conventional surgery, radiation therapy, cisplatin)
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.
Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
干预措施: Cisplatin (Drug)
Treatment (conventional surgery, radiation therapy, cisplatin)
Patients undergo radiotherapy daily on days 1-5 and receive concurrent cisplatin IV over 30 minutes on day 1. Treatment repeats weekly for approximately 6.5 weeks (a total of 32 fractions of radiotherapy) in the absence of unacceptable toxicity.
Six to eight weeks after the completion of chemoradiotherapy, patients with a complete clinical response may undergo incisional biopsy of the primary tumor and bilateral inguinal/femoral nodes (if the groin nodes were initially unresectable). Patients with microscopic or gross resectable residual disease may then undergo radical resection of the residual tumor. Patients with unresectable disease after the completion of chemoradiotherapy receive additional radiotherapy with 1-2 courses of concurrent cisplatin.
干预措施: Conventional Surgery (Procedure)
结局指标
主要结局
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
时间窗: Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment
Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0
Complete Clinical and Pathologic Response
时间窗: Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.
次要结局
未报告次要终点