IXO+A in mCRC With Liver-only Metastases
A Single-arm Phase II Downsizing Study of Irinotecan, Capecitabine and Oxaliplatin (IXO) and Bevacizumab as First-line Treatment to Assess Conversion to Resectability of Liver-only Metastases in Colorectal Cancer Patients With Initially Unresectable Metastases
The percentage of patients with defined unresectable metastatic disease who will benefit from a first-line treatment enabling secondary complete metastasectomy is unknown but limited. Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient populations.
This open label, multicentre Phase II study primarily aims to assess the resection rate achievable in a selected patient population with initially unresectable metastatic disease limited to the liver only in order to evaluate feasibility, safety and efficacy with regards to secondary resection of hepatic lesions in these patients.
The trial aims to enrol only patients meeting defined criteria of unresectability with regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order to examine the most appropriate, highly active treatment regimen for this group of unresectable patients with the highest probability of a successful secondary metastasectomy with curative intent. The trial will be conducted in highly specialized centres with a track record of successful interdisciplinary treatment approaches in the field of metastatic colorectal cancer to allow the precise assessment of the peri-operative safety parameters as well as an evaluation of the surgical treatment approaches.
The IXO regimen selected for this study has shown in a phase I/II study promising efficacy and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will allow evaluation of its potential benefit in combination with the two most active current chemotherapy regimens in the first-line and post-operative treatment setting.
調査の概要
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital Cancer Center
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto、Ontario、カナダ、M5T 2S8
- University Health Network
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Quebec
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Montreal、Quebec、カナダ、H3A 1A1
- McGill University Health Centre
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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:
- Primary colorectal cancer with unresectable metastatic lesion(s)
- At least one measurable lesion, confirmed by CT scan
- Male and female patients, aged ≥ 18 years
- ECOG performance score of 0 or 1 (within 1 week of study treatment start)
- Written informed consent
- Adequate general condition, cardiopulmonary functions and performance status
- Liver metastases no initially foreseen R0 resection of all hepatic lesions, but deemed potentially resectable after response to downsizing therapy
Exclusion Criteria:
- Extrahepatic metastatic disease
- Prior systemic or local treatment for metastatic disease, prior therapy with a biologic agent, prior adjuvant or neo-adjuvant chemotherapy, prior radiotherapy to the liver, other concurrent chemotherapy
- Inadequate bone marrow, liver, renal function, uncontrolled hypertension
- Pregnancy or lactation
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：なし
- 介入モデル：単一グループの割り当て
- 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：IXO+A
IXO regimen with Avastin
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IXO plus bevacizumab regimen is given every 3 weeks (Q3W), in the following order: Bevacizumab (A): 7.5 mg/kg via IV infusion, day 1 Oxaliplatin (O): 100 mg/m2 via 2-hour IV infusion, day 1 Irinotecan (I): 160 mg/m2 via 1-hour IV infusion, day 1 Capecitabine (X): 950 mg/m2 twice daily PO, days 2 - 15
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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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conversion to resectability during downsizing therapy with IXO+A patients with initially unresectable liver-only metastases associated with colorectal cancer
時間枠：after 8 IXO+A cycles
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after 8 IXO+A cycles
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Recurrence-free survival (RFS)
時間枠：Every 2 cycles
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Every 2 cycles
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Progression-free survival (PFS)
時間枠：Every 2 cycles
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Every 2 cycles
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Time to response (TTR)
時間枠：Every 2 cycles
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Every 2 cycles
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Overall survival (OS)
時間枠：Every 2 cycles
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Every 2 cycles
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Pathological complete response (pCR) rate
時間枠：assessed post-operatory
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assessed post-operatory
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Overall response rate (ORR)
時間枠：Every 2 cycles
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Every 2 cycles
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Number of participants with Adverse Events as a measure of Safety and Tolerability
時間枠：Every 3 weeks
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Every 3 weeks
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Surgical safety (frequency of surgical complications)
時間枠：assessed post-operatory
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assessed post-operatory
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Pathological changes in the non-tumoural liver following therapy with IXO+A
時間枠：assessed post-operatory
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assessed post-operatory
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R0, R1, R2 resection rate after up to 8 cycles of downsizing therapy with IXO+A
時間枠：assessed post-operatory
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assessed post-operatory
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協力者と研究者
捜査官
- スタディチェア：Jean Maroun, MD、The Ottawa Hospital Cancer Centre
研究記録日
主要日程の研究
研究開始
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OTT 10-01
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