Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer
Randomized Phase III Study Of Neoadjuvant Chemotherapy Followed By Surgery Vs. Concomitant Radiotherapy And Chemotherapy In FIGO Ib2, IIa>4 cm or IIb Cervical Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.
研究概览
地位
条件
详细说明
OBJECTIVES:
- Compare the overall and progression-free survival of patients with stage IB2, IIA, or IIB cervical cancer treated with neoadjuvant cisplatin-based chemotherapy followed by radical hysterectomy vs standard therapy comprising concurrent radiotherapy and cisplatin-based chemotherapy.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, FIGO stage, age (18 to 50 vs 51 to 75), and histological subtype (adenomatous vs non-adenomatous component). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive neoadjuvant cisplatin-based chemotherapy on day 1. Treatment repeats every 21 days. Within 6 weeks after the last chemotherapy course, patients undergo a type III-V Piver-Rutledge radical hysterectomy. Patients with positive lymph nodes or tumor invasion into the parametria or less than 5 mm from the resection borders after surgery receive standard adjuvant external beam radiotherapy once daily, 5 days a week, for 5-5.6 weeks (25-28 treatment days) followed by external boost radiotherapy or brachytherapy for 1 or 2 days.
- Arm II: Patients receive standard therapy comprising radiotherapy as in arm I concurrently with cisplatin-based chemotherapy once weekly for 6 weeks. Adjuvant hysterectomy is allowed, but not recommended, in case of histologically proven residual tumor.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. For patients in both arms, cisplatin may be combined with other chemotherapeutics as long as the minimum platinum dose is given.
Quality of life is assessed at baseline and at 6, 12, 18, and 24 months.
Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 686 patients (343 per treatment arm) will be accrued for this study within 3.8 years.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Graz、奥地利
- Karl-Franzens-University Graz
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Vienna、奥地利
- Kaiser Franz Josef Hospital
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Milano、意大利
- Istituto Europeo di Oncologia
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Monza、意大利
- Ospedale San Gerardo
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Naples、意大利
- Istituto Nazionale per lo Studio e la Cura dei Tumori
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Torino、意大利、10128
- Ospedale Mauriziano Umberto I
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Turin、意大利、10126
- Clinica Universitaria
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Varese、意大利
- Ospedale di Circolo e Fondazione Macchi
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Edegem、比利时
- Universitair Ziekenhuis Antwerpen
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Leuven、比利时
- U.Z. Gasthuisberg
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Liege、比利时、4000
- Centre Hospitalier Régional de la Citadelle
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Caen、法国
- Centre Regional Francois Baclesse
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Maidstone, Kent、英国
- Mid Kent Oncology Centre
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England
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Margate、England、英国
- Queen Elizabeth the Queen Mother Hospital
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Scotland
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Glasgow、Scotland、英国
- NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
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Amsterdam、荷兰、1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Amsterdam、荷兰
- Vrije Universiteit Medisch Centrum
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Enschede、荷兰
- Medisch Spectrum Twente
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Leiden、荷兰
- Leiden University Medical Center
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Nijmegen、荷兰
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam、荷兰、3008 AE
- Erasmus MC - Daniel den Hoed Cancer Center
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Utrecht、荷兰
- Universitair Medisch Centrum - Academisch Ziekenhuis
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Coimbra、葡萄牙
- Hospitais da Universidade de Coimbra (HUC)
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Madrid、西班牙
- Hospital Universitario San Carlos
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed cervical cancer, including the following subtypes:
- Squamous cell carcinoma
- Adenosquamous cell carcinoma
- Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma)
- FIGO stage IB2, IIA (greater than 4 cm), or IIB
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.46 mg/dL
Renal:
- Creatinine clearance greater than 60 mL/min
Other:
- No other prior or concurrent malignancy except adequately treated basal cell skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent anticancer agent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Chemotherapy followed by surgery
neoadjuvant chemotherapy (Cisplatin) followed by surgery (radial hysterectomy)
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Radial hysterectomy
Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2.
Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
Minimal cumulative 225 mg/m2 (experimental arm).
Cumulative 200-240 mg/m2 (comparator arm).
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有源比较器：Radio-chemotherapy
Concomitant radiotherapy (external radiotherapy combined with external boost or brachytherapy) and chemotherapy (cisplatin)
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Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2.
Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.
Minimal cumulative 225 mg/m2 (experimental arm).
Cumulative 200-240 mg/m2 (comparator arm).
Brachytherapy at the end of external radiation.
Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.
Between 45-50 Gy, in fractions of 1.8 to 2 Gy.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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5 年总生存率
大体时间：5年
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5年
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合作者和调查者
调查人员
- 学习椅：Fabio Landoni, MD、Istituto Europeo Di Oncologia, Milano
- 学习椅：Alessandro Colombo, MD、Ospedale Alessandro Manzoni, Lecco
- 学习椅：Stefano Greggi, MD, PhD、Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli
- 学习椅：Gemma G. Kenter, MD、Academisch Medisch Centrum - Universiteit van Amsterdam
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.