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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Maidstone, Kent、イギリス
- Mid Kent Oncology Centre
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England
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Margate、England、イギリス
- Queen Elizabeth the Queen Mother Hospital
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Scotland
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Glasgow、Scotland、イギリス
- NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
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Milano、イタリア
- Istituto Europeo di Oncologia
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Monza、イタリア
- Ospedale San Gerardo
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Naples、イタリア
- Istituto Nazionale per lo Studio e la Cura dei Tumori
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Torino、イタリア、10128
- Ospedale Mauriziano Umberto I
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Turin、イタリア、10126
- Clinica Universitaria
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Varese、イタリア
- Ospedale di Circolo e Fondazione Macchi
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Amsterdam、オランダ、1105 AZ
- Academisch Medisch Centrum at University of Amsterdam
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Amsterdam、オランダ
- Vrije Universiteit Medisch Centrum
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Enschede、オランダ
- Medisch Spectrum Twente
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Leiden、オランダ
- Leiden University Medical Center
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Nijmegen、オランダ
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam、オランダ、3008 AE
- Erasmus MC - Daniel den Hoed Cancer Center
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Utrecht、オランダ
- Universitair Medisch Centrum - Academisch Ziekenhuis
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Graz、オーストリア
- Karl-Franzens-University Graz
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Vienna、オーストリア
- Kaiser Franz Josef Hospital
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Madrid、スペイン
- Hospital Universitario San Carlos
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Caen、フランス
- Centre Regional Francois Baclesse
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Edegem、ベルギー
- Universitair Ziekenhuis Antwerpen
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Leuven、ベルギー
- U.Z. Gasthuisberg
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Liege、ベルギー、4000
- Centre Hospitalier Regional de la Citadelle
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Coimbra、ポルトガル
- Hospitais da Universidade de Coimbra (HUC)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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5年後の全生存率
時間枠：5年
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5年
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協力者と研究者
捜査官
- スタディチェア：Fabio Landoni, MD、Istituto Europeo Di Oncologia, Milano
- スタディチェア：Alessandro Colombo, MD、Ospedale Alessandro Manzoni, Lecco
- スタディチェア：Stefano Greggi, MD, PhD、Istituto Nazionale per lo Studio e la Cura dei Tumori, Napoli
- スタディチェア：Gemma G. Kenter, MD、Academisch Medisch Centrum - Universiteit van Amsterdam
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。