Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma
2018年6月20日 更新者：University of Michigan Rogel Cancer Center
A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma
This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).
This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.
調査の概要
状態
引きこもった
条件
研究の種類
介入
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- The University of Michigan Comprehensive Cancer Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is defined as having at least one of the following:
- HCC diagnosed either on biopsy or based on standard imaging criteria on contrast enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or
- A discrete hepatic tumor(s) as defined by the Barcelona criteria10 for cirrhotic patients, >1 cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI
- Presentation at multidisciplinary liver tumor board to assess eligibility for either SBRT or MWA
- Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse hepatic resection. Patients who are on the organ wait list for (orthotopic liver transplantation) OLT will be considered for this trial as a "bridge" to transplant.
- Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5 cm in diameter or less and the combined diameter of both lesions is 5 cm or less.
- The foci of HCC must be in an anatomic location amendable to treatment by both MWA and SBRT.
- The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology Group Performance Status is an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death).
- Patients must have recovered from the acute effects of prior liver-directed therapy (e.g., RT, RFA, MWA or TACE) and a minimum of 4 weeks must have passed since the last procedure and protocol therapy.
Patients must have:
- Platelets ≥ 50,000/mm3
- Child Pugh class A liver function or class B7 (Appendix II)
- INR (international normalized ratio (for anticoagulant monitoring)) < 1.5
- The patient must have a life expectancy of at least 12 weeks
- The patient must be at least 18 years old
- Patients must sign an IRB approved informed consent form for this purpose indicating that they are aware of the investigational aspects of the treatment and the potential risks. They also must be able to understand and the willing to sign a written informed consent.
Exclusion Criteria:
- Patients who have received prior abdominal radiation
- Patients with 3 or more foci of HCC
- Patients whose HCC involves the local vasculature, regional lymph nodes or distant metastatic sites
- Patients with Child Pugh liver function worse than B7
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：MWA
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
|
MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
|
|
実験的：SBRT
SBRT will be administered in five fractions of up to 10 Gy per fraction.
SBRT will be administered 5-15 days per tumor.
|
SBRT will be administered in five fractions of up to 10 Gy per fraction.
SBRT will be administered 5-15 days per tumor.
|
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 |
|---|---|---|
|
Time to local tumor progression
時間枠：Patients will be followed up to 2 years
|
The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT.
Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression.
Tumors falling to group PD (progressive disease) would constitute local control failures.
Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded.
Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started.
Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.
|
Patients will be followed up to 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of gastrointestinal (GI) and hepatobiliary toxicity
時間枠：Patients will be followed up to 2 years
|
The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
|
Patients will be followed up to 2 years
|
|
Incidence of liver function worsening
時間枠：Patients will be followed up to 2 years
|
The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.
|
Patients will be followed up to 2 years
|
|
Change in FACT- Hep questionnaire score
時間枠：Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
|
The FACT-Hep questionnaire is used to measure health-related quality of life (HRQoL) in patients with hepatobiliary cancers.
They are asked questions about their physical, social, emotional and functional well-being and asked to provide a score between 0 and 4 where 0 represents not at all and 4 represents very much.
|
Questionnaires will be administered pre-treatment, post-treatment, and at 1, 3 ,6, 9, 12, 15, 18, 21, and 24 months post-treatment
|
|
Overall survival time
時間枠：Patients will be followed up to 2 years
|
Overall survival (OS) is defined as the time from randomization to death from any cause.
Patients who are alive at last follow-up will be censored on that date.
|
Patients will be followed up to 2 years
|
|
Progression free survival time
時間枠：Patients will be followed up to 2 years
|
Progression Free Survival (PFS) is defined as the minimum time to death or any progression.
|
Patients will be followed up to 2 years
|
|
Metastasis free survival time
時間枠：Patients will be followed up to 2 years
|
Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.
|
Patients will be followed up to 2 years
|
|
Incidence of intrahepatic failure
時間枠：Patients will be followed up to 2 years
|
Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.
|
Patients will be followed up to 2 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Dawn Owen, M.D., Ph.D.、University of Michigan Rogel Cancer Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年5月11日
一次修了 (予想される)
2022年4月1日
研究の完了 (予想される)
2022年4月1日
試験登録日
最初に提出
2017年5月17日
QC基準を満たした最初の提出物
2017年5月24日
最初の投稿 (実際)
2017年5月30日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月25日
QC基準を満たした最後の更新が送信されました
2018年6月20日
最終確認日
2018年6月1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。
がん、肝細胞の臨床試験
-
Taichung Veterans General Hospital完了心毒性 | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung） | 薬物関連の副作用および有害反応（MeSH用語） | EGFRチロシンキナーゼ阻害剤台湾
-
Fondazione del Piemonte per l'Oncologia募集乳がん | 卵巣がん | 結腸直腸がん | 黒色腫 (皮膚がん) | 非小細胞肺癌（MeSH用語：Carcinoma, Non-Small-Cell Lung）イタリア
Microwave Ablation (MWA)の臨床試験
-
Shanghai MicroPort EP MedTech Co., Ltd.まだ募集していません
-
Pier LambiaseUniversity Hospital Southampton NHS Foundation Trust; The Royal Bournemouth Hospital完了
-
The University of Hong Kong募集