Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases (ATOM)
Randomized Phase II Study of mFOLFOX6 + Bevacizumab or mFOLFOX6 + Cetuximab in Liver Only Metastasis From KRAS Wild Type Colorectal Cancer
調査の概要
状態
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
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Tokyo
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Shinjuku-ku、Tokyo、日本、162-0814
- EPS Corporation
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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:
- Histopathologically confirmed colorectal cancer (adenocarcinoma) excluding vermiform appendix cancer and proctos cancer.
- RAS wild type
Synchronous* or metachronous liver limited meitastasis with no extrahepatic desiease
- shychronous liver limited metastasis with primary lesion less than two thirds of the circumference
- patients with primary lesion more than two thirds of the circumference can be enrolled after primary resection
- Patients who has one or more lesion(s) of diameter 1 cm or larger (RECEST v1.1) be able to assess continuously on the basis of the protocol by contrast enhanced CT or contrast enhanced MRI of the liver:
(1)Liver metastases 5 or more (2)Liver metastases with 5 cm or larger in greatest dimension (3)Unresectable considering remaining hepatic function (4)Invasion into all hepatic veins or inferior vena cava (5)Invasion into both right and left hepatic arteries or portal veins 5.No prior chemotherapy for colorectal cancer including hepatic arterial infusion. Excluding postoperative and preoperative chemoradiotherapy except for rectal cancer with synchronous liver metastases. Patients received postoperative chemotherapy containing oxaliplatin have to be enrolled after 24 weeks from the last oxaliplatin administration.
6.No previous treatment including ablation therapy, cryotherapy and chemotherapy for metastases 7.Age at enrollment is >=20 and =<80 years 8.The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 9.Life expectancy from the day of enrollment is 3 months or longer 10.Major organ functions less than 14 days prior to entry meet the following criteria.
- Neu >= 1500/mm3
- Pt >= 10.0x10^4/mm3
- Hb >= 9.0 g/dL
- T-bil =< 2.0 mg/dL
- AST and ALT =< 200 IU/L
- sCr =< 1.20 mg/dL
- INR < 1.5
- Proteinuria =< 2+ 11.Written informed consent
Exclusion Criteria:
- Previously experienced severe allergic reaction to drugs
- Receiving anti-platelet drugs (aspirin >= 325 mg/day) or NSAIDs
- Receiving chronic systemic corticosteroid treatment
- Surgery/ biopsy with skin incision or traumatic injury with suture less than 14 days prior to entry. Excluding, suture for implanted venous reservoirs with catherter is allowed.
- Severe postoperative complications (e.g. postoperative infection, anastomic dehiscence or paralytic ileus)
- Diagnosed as hereditary colorectal cancer
- Active other malignancies
- Cerebrovascular disease or symptoms less than 1 year prior to entry
- Pleural effusion, ascites or cardiac effusion requiring drainage
- Hemorrhage/bleeding, paralytic ileus, obstruction or ulceration of gastrointestinal tract
- Perforation of gastrointestinal tract less than 1 year prior to entry
- Presence of active infection
- HBs antigen or HCV antibody positive
- Uncontrolled comorbidity including hypertension, diabetes, arrhythmia, or other diseases (such as cardiac disorder, interstitial pneumonia or renal disorder)
- Presence of >= grade 2 diarrhea
- Presence of >= grade 1 peripheral neuropathy
- Pregnant or lactating women. Women and men with childbearing potential unwilling to use effective means of contraception
- Psychosis or psychiatric symptoms who are not able to comply with the protocol
- Any other medical conditions disable to comply with the protocol
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 |
|---|---|
|
実験的:mFOLFOX + Bmab
mFOLFOX plus bevacizumab
|
5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
|
|
アクティブコンパレータ:mFOLFOX + Cmab
mFOLFOX plus cetuximab
|
85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
他の名前:
250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle.
Liver resection if resectable after 8 cycles or continue until progression of disease.
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free survival
時間枠:assessed every 8 weeks, up to 4 years
|
assessed by Independent Review Committee
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assessed every 8 weeks, up to 4 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Response rate
時間枠:assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tumor shrinkage rate at 8 week
時間枠:assessed at 8 week, up to 8 weeks
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assessed at 8 week, up to 8 weeks
|
|
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Liver resection rate
時間枠:assessed every 8 weeks, up to 4 years
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assessed every 8 weeks, up to 4 years
|
|
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R0 liver resection rate
時間枠:assessed every 8 weeks, up to 4 years
|
pathologically confirmed R0 liver resection rate
|
assessed every 8 weeks, up to 4 years
|
|
Progression-free survival
時間枠:assessed every 8 weeks, up to 4 years
|
assessed by investigators
|
assessed every 8 weeks, up to 4 years
|
|
Time to treatment-failure
時間枠:assessed every 2 weeks, up to 4 years
|
assessed every 2 weeks, up to 4 years
|
|
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Overall survival
時間枠:assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
|
|
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Quality of life
時間枠:assessed every 16 weeks, up to 1 year
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assessed every 16 weeks, up to 1 year
|
|
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Incidence of adverse events
時間枠:assessed every 2 weeks, up to 4 years
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assessed every 2 weeks, up to 4 years
|
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Progression-free survival among the RAS wild type subpopulation
時間枠:assessed every 8 weeks, up to 4 years
|
All the assessment is repeated for a maximum of 4 years.
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assessed every 8 weeks, up to 4 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Yoshihiko Maehara, MD,PhD,FACS、Graduate School of Medical Science, Kyushu University, Department of Surgery and Science
- 主任研究者:Naohiro Tomita, MD, PhD、Hyogo College of Medicine, Department of Surgery
- 主任研究者:Ichinosuke Hyodo, MD, PhD、Tsukuba University, Graduate School of Medicine
- 主任研究者:Michiaki Unno, MD, PhD、Tohoku University, Division of Gastroenterological Surgery
出版物と役立つリンク
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 (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
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
- ATOM (Radius Health, Inc.)
- UMIN000010209 (その他の識別子:UMIN)
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