Clinical Trial to Assess the Importance of Nephrectomy (CARMENA)
Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib
調査の概要
詳細な説明
The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell carcinoma have justified recommendation to initial nephrectomy for patients presenting with metastatic renal cell carcinoma. But these studies were performed at the time of immunotherapy.
The objective is Evaluation of the importance of nephrectomy in patients with metastatic renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be 50 mg daily with provision for dose reduction based on tolerability Patient will be treated until disease progression or unacceptable toxicity occurrence or withdraw.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Paris、フランス、75015
- Hopital Necker
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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
Inclusion Criteria:
- age ≥ 18 years
- ECOG Performance Status 0 - 1
- Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
- Documented metastatic disease
- Absence of prior systemic treatment for kidney cancer including AA
- Tumour amenable to nephrectomy (partial or total) in the opinion of the patient's urologist. Patients presenting with an inferior vena cava thrombosis can be included.
- Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment.
- Platelets > or = 100 x 109/L, haemoglobin >or = 9 g/dl, neutrophils >or = 1.5 x 109/L;
- Bilirubin < or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)< or = 2.5 times the upper normal limit (UNL) or < or = 5 times UNL for patients with liver metastases
- Patients of child bearing age should use contraceptive methods
- Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
- Life expectancy ≥ 3 months
- Written informed consent
- Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
- Patient non treated by anticoagulants excepted HBPM
Exclusion Criteria:
- Prior systemic treatment for kidney cancer (including Anti Angiogenic)
- Bilateral kidney cancer
- Pregnant or breast feeding women
- Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis not treated with low molecular weight heparin or arterial thrombosis within the last 3 months
- Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included)
- Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
- Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included)
- Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib
- Experimental treatment within the 28 days preceding inclusion
- Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
- Patient has received treatment with IV biphosphonate
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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アクティブコンパレータ:A
Nephrectomy + sunitinib
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Current surgery
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実験的:B
Sunitinib alone
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Sunitinib alone without nephrectomy
他の名前:
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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 |
---|---|
The primary endpoint is overall survival.
時間枠:starting at 4 months
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starting at 4 months
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二次結果の測定
結果測定 |
時間枠 |
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Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria
時間枠:Starting at 4 months
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Starting at 4 months
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Clinical benefit (complete response, partial or stable for at least 12 weeks).
時間枠:Starting at 4 months
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Starting at 4 months
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Progression-Free Survival
時間枠:Starting at 4 months
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Starting at 4 months
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Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy
時間枠:Starting at 4 months
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Starting at 4 months
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Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy
時間枠:Starting at 4 months
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Starting at 4 months
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Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy
時間枠:Starting at 4 months
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Starting at 4 months
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協力者と研究者
協力者
捜査官
- 主任研究者:Arnaud Mejean, MD PhD、Assistance Publique - Hôpitaux de Paris
出版物と役立つリンク
一般刊行物
- Mejean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Beisland C, Aitchison M, Oudard S, Patard JJ, Theodore C, Chevreau C, Laguerre B, Hubert J, Gross-Goupil M, Bernhard JC, Albiges L, Timsit MO, Lebret T, Escudier B. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018 Aug 2;379(5):417-427. doi: 10.1056/NEJMoa1803675. Epub 2018 Jun 3.
- Leon L, Garcia-Figueiras R, Suarez C, Arjonilla A, Puente J, Vargas B, Mendez Vidal MJ, Sebastia C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12. Erratum In: Target Oncol. 2014 Jun;9(2):181. Garcia-Figueras, Roberto [corrected to Garcia-Figueiras, Roberto].
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
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