Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model (NEXT-1)
Next pErsonalized Cancer tX With mulTi-omics and Preclinical Model: The Master Protocol
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.
To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling and receive molecular profile directed treatments.
調査の概要
状態
条件
詳細な説明
This study nickname is NEXT-1 trial(Next pErsonalized cancer tX with mulTi). A single-center, open label trial to analysis of genetic information in advanced cancer.
If the target is to be confirmed by molecular profile, the subgroup is going to Umbrella trial type.
defined below: NEXT 1 trial is screening and feasibility -> NEXT trial is BASKET/umbrella study screening protocol(Molecular screening prolongs survival)->NEXT-1.1(gastric cancer),NEXT-1.2(colorectal cancer),NEXT-1.3(biliary tract cancer/pancreatic cancer),NEXT-1.4(Rare cancer),NEXT-1.5(genitourinary cancer)
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Seoul、大韓民国、99999
- Samsung Medical Center
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- pathologically confirmed metastatic malignancy
- Written informed consent
Exclusion Criteria:
- patients who do not agree with biopsy
- patients who do not have enough tissue for acquisition
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
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
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gastric cancer
This study will recruit a total of 130 gastric cancer patients.
It is expected to recruit about 250 gastric cancer patients per year.
Since the incidence of each mutation is low, the different types of mutations are assumed to be mutually exclusive.
So, about 30% of these patients are expected to have a mutation with a target drug.
Overall response (OR) is the primary endpoint of this study.
OR rate (ORR) will be compared between the group (called targeted group) of patients who have a mutation with a target drug and that (called untargeted group) of patients who have no mutation.
The ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group.
With N=130 gastric cancer patients, about 39 patients will belong to the targeted group and about 91 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 89% of power.
The study on gastric cancer will take 7 months for patient accrual.
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colorectal cancer
This study will recruit a total of 130 colorectal cancer patients.
It is expected to recruit about 300 colorectal cancer patients per year.
About 25% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The median ORR is expected to be about 25% for the targeted group and about 5% for the untargeted group.
With N=130 colorectal cancer patients, about 33 patients will belong to the targeted group and about 97 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 87% of power.
The study on colorectal cancer will take about 6 months for accrual.
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biliary tract cancer/pancreatic cancer
This study will recruit a total of 78 biliary tract cancer/pancreatic cancer patients.
It is expected to recruit about 100 biliary tract cancer/pancreatic cancer patients per year.
About 20% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The ORR is expected to be about 35% for the targeted group and about 5% for the untargeted group.
With N=78 biliary tract cancer/pancreatic cancer patients, about 16 patients will belong to the targeted group and about 62 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 87% of power.
The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
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Rare cancer
Rare cancer is hepatocellular carcinoma, melanoma and neuroendocrine tumor.
This study will recruit a total of 87 hepatocellular carcinoma/rare cancer patients.
It is expected to recruit about 150 biliary tract cancer/pancreatic cancer patients per year.
About 25% of these patients are expected to have a mutation with a target drug.
ORR will be compared between the targeted group and the untargeted group.
The ORR is expected to be about 30% for the targeted group and about 5% for the untargeted group.
With N=87 biliary tract cancer/pancreatic cancer patients, about 22 patients will belong to the targeted group and about 65 will belong to the untargeted group.
The chi-square test with a 2-sided alpha=5% has 86% of power.
The study on biliary tract cancer/pancreatic cancer will take about 7 months for accrual.
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genitourinary cancer
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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 |
---|---|---|
Response rate
時間枠:expected average of 3 years
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To compare response rate (RR) (per RECIST 1.1) in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus RR in patient cohort with non-matched treatment based on molecular profiling
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expected average of 3 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Progression Free Survival
時間枠:expected average of 3 years
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To compare PFS in patient cohort with molecularly matched treatment (in practice or in the context of clinical trials) versus PFS in patient cohort with non-matched treatment based on molecular profiling
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expected average of 3 years
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feasibility
時間枠:expected average of 3 years
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To evaluate changes in the tumor's molecular profile on serial biopsies
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expected average of 3 years
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feasibility
時間枠:expected average of 3 years
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To establish n of 1 preclinical model for each patient whenever feasible
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expected average of 3 years
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協力者と研究者
スポンサー
捜査官
- スタディチェア:Won Ki Kang, MD、Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
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 (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。
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