GBM切除と標準的なケアでのガンマティールですぐに放射線を開始 (BRIDGES)
切除およびGammatile®のランダム化研究に続いて、新たに診断された膠芽腫（GBM）における同時外ビーム放射線療法（EBRT）とテモゾロミド（TMZ）およびアジュバントTMZ対標準ケアが続きます
This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:
- A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.
- A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).
- An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.
- An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm.
- An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.
- An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.
For any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Kimberly Johnson
- 電話番号：(833)662-0044
- メール：kjohnson@gammatile.com
研究場所
-
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Arizona
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Scottsdale、Arizona、アメリカ、85251
- 募集
- HonorHealth Scottsdale Osborn Medical Center
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主任研究者：
- John Wanebo, MD
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コンタクト：
- Maria Canchola, BSN, RN-BC
- メール：mcanchola@honorhealth.com
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California
-
Los Angeles、California、アメリカ、90048
- 募集
- Cedars Sinai Medical Center
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コンタクト：
- Jeremy D. Rudnick, MD
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主任研究者：
- Jeremy D. Rudnick, MD
-
Los Angeles、California、アメリカ、90033
- 募集
- Keck Medicine of USC
-
主任研究者：
- Eric Chang, MD
-
コンタクト：
- Lorraine Martinez Seng, BSN, RN
- メール：Lorraine.Martinez@med.usc.edu
-
San Francisco、California、アメリカ、94115
- 募集
- Sutter Health
-
コンタクト：
- Patricia Seid, MD
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主任研究者：
- Patricia Seid, MD
-
San Francisco、California、アメリカ、94143
- 募集
- University of California San Fransico
-
コンタクト：
- Jacob Young, MD
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主任研究者：
- Jacob Young, MD
-
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Colorado
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Littleton、Colorado、アメリカ、80122
- 募集
- Advent Health - Colorado
-
コンタクト：
- Darlene Bugoci, MD
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主任研究者：
- Darlene Bugoci, MD
-
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Florida
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Orlando、Florida、アメリカ、32804
- 募集
- Advent Health
-
コンタクト：
- Jack Ramsberger
- メール：jack.ramsberger@adventhealth.com
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主任研究者：
- Imran Mohiuddin, MD, PhD
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Georgia
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Atlanta、Georgia、アメリカ、30322
- 募集
- Emory Winship Cancer Institute
-
コンタクト：
- Winship Clinical Trial Office
- 電話番号：404-778-1868
- メール：winshipcto@emory.edu
-
主任研究者：
- Kimberly B. Hoang, MD
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Illinois
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Chicago、Illinois、アメリカ、60607
- 募集
- Rush University Medical Center
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主任研究者：
- Ken Tatebe, MD, PhD
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コンタクト：
- Ken Tatebe, MD, PhD
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Kentucky
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Louisville、Kentucky、アメリカ、40241
- 募集
- Norton Cancer Institute - Brownsboro
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主任研究者：
- Parag Sevak, MD
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コンタクト：
- Parag Sevak, MD
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Maryland
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Baltimore、Maryland、アメリカ、21287
- 募集
- Johns Hopkins University
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コンタクト：
- Jordina Rincon-Torroella, MD
- 電話番号：410-955-1040
- メール：jrincon2@jhmi.edu
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主任研究者：
- Jordina Rincon-Torroella, MD
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Missouri
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Columbia、Missouri、アメリカ、65201
- 募集
- University of Missouri
-
コンタクト：
- Gregory Biedermann, MD
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主任研究者：
- Gregory B. Biedermann, MD
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03766
- 募集
- Dartmouth Hitchcock Medical Center
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主任研究者：
- Linton Evans, MD
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コンタクト：
- Cancer Research Nurse
- メール：cancer.research.nurse@hitchcock.org
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New Jersey
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Neptune City、New Jersey、アメリカ、07753
- 募集
- Jersey Shore University Medical Center | Hackensack
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主任研究者：
- Nitesh Patel, MD
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コンタクト：
- Diane Doherty, MSN, RN-BC, OCN
- メール：diane.doherty@hmhn.org
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New York
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Valhalla、New York、アメリカ、10595
- 募集
- Westchester Medical Center
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主任研究者：
- Simon Hanft, MD
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コンタクト：
- Cristina Falo, PhD
- メール：Cristina.Falo@wmchealth.org
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副調査官：
- Rohil Shekher, MD
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North Carolina
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Greenville、North Carolina、アメリカ、27834
- 募集
- East Carolina University
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主任研究者：
- K. Stuart Lee, MD
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コンタクト：
- Shayla Vickers, RN
- メール：Shayla.Vickers@ecuhealth.org
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Ohio
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Columbus、Ohio、アメリカ、43210
- 募集
- The Ohio State University
-
主任研究者：
- James B Elder, MD
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コンタクト：
- James B Elder, MD
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15212
- 募集
- Allegheny Health Network
-
主任研究者：
- Matthew Shepard, MD
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コンタクト：
- Sarah Kimutis
- 電話番号：724-228-1414
- メール：Sarah.Kimutis@ahn.org
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- 募集
- Brown University Health
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主任研究者：
- Clark Chen, MD, PhD
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コンタクト：
- Maria Duffy
- メール：mduffy@brownhealth.org
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- 募集
- Medical University of South Carolina
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主任研究者：
- Charlotte Rivers, MD
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コンタクト：
- Clinical Trial Office
- 電話番号：843-792-9321
- メール：hcc-clinical-trials@musc.edu
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Texas
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Houston、Texas、アメリカ、77030
- 募集
- Houston Methodist
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コンタクト：
- Melissa Daly, RN
- メール：mrdaly@houstonmethodist.org
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主任研究者：
- David Baskin, MD
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Virginia
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Fairfax、Virginia、アメリカ、22031
- 募集
- Inova Schar Cancer Institute
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コンタクト：
- Kevin Choe, MD, PhD
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主任研究者：
- Kevin Choe, MD, PhD
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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
Major Criteria Includes the Following:
Inclusion Criteria
-
Patients must be ≥18 years of age.
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Have radiographic suspicion of newly diagnosed glioblastoma (GBM).
o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.
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Are medically and surgically appropriate for resection.
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Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.
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Are able to receive standard of care treatment.
Exclusion Criteria
- A previous biopsy diagnosis other than IDH wild-type GBM.
- Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.
- Have multi-focal enhancing tumors that cannot be encompassed in one operative field.
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 |
|---|---|
|
アクティブコンパレータ：Maximal safe resection followed by EBRT with concurrent TMZ followed by adjuvant TMZ (Arm A)
All patients will undergo tumor resection. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 30-fraction course of EBRT for 6 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. |
External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body
他の名前：
TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor
他の名前：
|
|
実験的：Maximal safe resection + GammaTile followed by EBRT with concurrent TMZ then adjuvant TMZ (Arm B)
All patients will undergo tumor resection + GammaTile implantation. Start TMZ (75 mg/m2/day orally) on the first day of EBRT and will be administered concurrently with EBRT, up to 5 days per week, for the 20-fraction course of EBRT for 4 weeks within 30±10 days post-surgery. After EBRT and concurrent TMZ phase, the first cycle begins 28 ±7 days following the last day of the EBRT and Concurrent TMZ Phase. Adjuvant TMZ includes 5 days of TMZ treatment at the start of each 28-day cycle. Additional cycles (up to a maximum of 12), which may be given at the discretion of the Investigator, will be documented, and performed in the same manner as done in the first 6 cycles. |
External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body
他の名前：
TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor
他の名前：
GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds |
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 |
|---|---|---|
|
Overall Survival
時間枠：Days from surgery to death.
|
The primary endpoint of the study is OS, defined as the day from surgery to death. Patients who are still alive (or lost to follow-up) at the time of data analysis will be censored at the last time point they were known to be alive. |
Days from surgery to death.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression Free Survival
時間枠：Days from surgery to death or disease progression.
|
To compare PFS, defined as days from surgery to death or disease progression, between the 2 study arms based on the most current RANO Resect Group criteria; |
Days from surgery to death or disease progression.
|
|
Time to next unplanned treatment
時間枠：Time to next unplanned treatment.
|
To compare the time to next unplanned treatment per study arm |
Time to next unplanned treatment.
|
|
Performance Status
時間枠：24 months.
|
To assess the performance status up to 24 months |
24 months.
|
|
Safety Assessment
時間枠：Study duration.
|
To assess the nature, severity, and frequency of AEs between the 2 study arms based on the most current CTCAE criteria |
Study duration.
|
|
Quality of Life Assessments
時間枠：COST-Score duration of study; FACT-Br up to 12 months after randomization.
|
Financial toxicity scale (Comprehensive Score for Financial Toxicity [COST]-score) and functional assessment of cancer therapy - brain (FACT-Br) up to 12 months after randomization. |
COST-Score duration of study; FACT-Br up to 12 months after randomization.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
- GTM-105
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。