NCT00462397Unknown2 期
Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
University College London Hospitals6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2005年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, carboplatin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin followed by cisplatin and radiation therapy works in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate, in terms of clinical or radiologic response at 12 weeks after completion of study therapy, in patients with stage IB2-IVA cervical cancer treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy.
Secondary
- Determine the response rate in patients treated with this neoadjuvant chemotherapy regimen.
- Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients.
- Assess the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed carcinoma of the cervix, including any of the following subtypes:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Adenosquamous cell carcinoma
- •Locally advanced disease (i.e., FIGO stage IB2-IVA disease)
- •Stage confirmed by examination under anesthesia, cystoscopy, and sigmoidoscopy with biopsy of any suspicious lesions in the bladder, vagina, or rectum
- •Disease suitable for treatment with radical intent using chemoradiotherapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 12.5 g/dL
- •WBC > 3,000/mm^3
- •Absolute neutrophil count > 1,500/mm^3
- •Bilirubin < 1.25 times upper limit of normal (ULN)
- •Glomerular filtration rate (GFR) normal by ethylenediaminetetraacetic acid (EDTA) OR creatinine clearance ≥ 60 mL/min
- •Placement of ureteric stents required for all patients with hydronephrosis, regardless of renal function
- •ALT or AST < 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •No prior diagnosis of cancer, except basal cell skin cancer
- •No active cardiac disease
- •Deemed fit to receive chemoradiotherapy
- •ECG normal
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Response rate at the end of chemoradiotherapy (i.e., 12 weeks after completion of study therapy)
次要结局
- Overall survival
- Response rate at the end of neoadjuvant treatment (i.e., 6 weeks after study entry)
- Toxicity as assessed by NCI CTCAE v3.0
- Progression-free survival
研究者
研究点 (6)
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