緩徐進行性非ホジキンリンパ腫の治療のための線量低減放射線療法
緩徐進行性非ホジキンリンパ腫（POSEIDON）に対する低線量低分割放射線療法（3Gy x 3回）：多施設第2相ランダム化試験
This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVE:
I. To show that the experimental arm [9 gray (Gy) in 3 fractions, 8 Gy in 2 fractions, or 10 Gy in 5 fractions] has significantly reduced acute toxicity (grade ≥ 2 adverse events at least possibly related to radiation treatment within 14 days after the end of radiation treatment [according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0] compared to 24 Gy in 12 fractions.
SECONDARY OBJECTIVES:
I. To evaluate patient reported quality of life. II. To evaluate response rate. III. To evaluate local control rate. IV. To evaluate relapse-free survival.
EXPLORATORY OBJECTIVES:
I. Financial toxicity will be assessed at the end of radiation treatment. II. Financial health care expenditure will be assessed at the end of radiation treatment III. Late toxicity.
CORRELATIVE RESEARCH OBJECTIVES:
I. Biopsies of enrolled patients will be evaluated for pathological assessment of cellular and genetic mutations to correlate them with disease local relapse and radiation resistance.
II. Patients will have their baseline positron emission tomography (PET)/computed tomography (CT) scan undergo auto-segmentation to calculate the functional imaging 18-fluoro-deoxyglucose (FDG) metabolic tumor volume (MTV), total lesions glycolysis (TLG) and maximum standardized uptake volume (SUVmax) of the sites to be treated with involved-site radiation therapy (ISRT) using MIMvista platform to correlate it with disease local relapse and treatment response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo reduced dose ISRT once daily (QD) over 3, 2, or 5 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
ARM II: Patients undergo standard of care (SOC) radiation therapy QD over 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up.
After completion of study treatment, patients are followed up at days 7 and 14, months 3 and 6, and then every 6 months for up to 2 years post-radiation therapy.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究場所
-
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Arizona
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Scottsdale、Arizona、アメリカ、85259
- 募集
- Mayo Clinic in Arizona
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コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- William G. Rule, MD
-
-
Florida
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Jacksonville、Florida、アメリカ、32224-9980
- 募集
- Mayo Clinic in Florida
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- Brad S. Hoppe, MD, MPH
-
-
Minnesota
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Albert Lea、Minnesota、アメリカ、56007
- 募集
- Mayo Clinic Health System in Albert Lea
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- John Yeakel, MD
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Mankato、Minnesota、アメリカ、56001
- 引きこもった
- Mayo Clinic Health System - Mankato
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Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic in Rochester
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- Scott C. Lester, MD
-
-
Wisconsin
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Eau Claire、Wisconsin、アメリカ、54701
- 募集
- Mayo Clinic Health System-Eau Claire Clinic
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- Now Bahar Alam, MD
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La Crosse、Wisconsin、アメリカ、54601
- 募集
- Mayo Clinic Health System-Franciscan Healthcare
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- Abigail L. Stockham, MD
-
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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:
-
Age ≥ 18 years
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Histological confirmation of indolent B-cell lymphoma that can include any of the following:
- Follicular lymphoma (grade 1 or 2 or 3A)
- Marginal zone lymphoma (nodal or extranodal)
- Follicle center lymphoma
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Any stage disease
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Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3
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Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only
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Provide written informed consent
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Ability to complete questionnaire(s) by themselves or with assistance
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Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items
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Confirmation from radiation oncologist of suitability to participate in study
Exclusion Criteria:
-
Any of the following:
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
-
T-cell lymphoma
-
Receiving treatment for small and chronic lymphocytic lymphoma
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Grade 3B follicular lymphoma
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：ARM 1 (reduced dose ISRT)
Patients undergo reduced dose ISRT once daily (excluding weekends): 9 Gy delivered in 3 treatment fractions or 8 Gy in 2 fractions. At physician discretion, patients may receive 10 Gy in 5 fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
他の名前：
Undergo PET/CT
他の名前：
Undergo endoscopy
他の名前：
Undergo ISRT in 3 fractions
他の名前：
|
|
アクティブコンパレータ：ARM 2 (SOC ISRT)
Patients undergo standard of care (SOC) radiation therapy once daily (excluding weekends): 24 Gy in 12 treatment fractions. Patients also undergo CT or PET/CT throughout the study. Patients may additionally undergo endoscopy during screening and during follow up. |
Ancillary studies Undergo CT or PET/CT
他の名前：
Undergo PET/CT
他の名前：
Undergo endoscopy
他の名前：
Undergo ISRT in 12 fractions
他の名前：
|
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 |
|---|---|---|
|
Incidence of grade 2 or higher acute adverse events (AEs)
時間枠：Up to 14 days after radiation treatment
|
AEs will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity will be reported as a proportion calculated as the number of patients with acute toxicity divided by the total number of treatment patients. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 14 days after radiation treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response rate
時間枠：Up to 3 months after radiation treatment
|
Response rate will be defined as the proportion of patients displaying response (complete response or partial response) at 3 months post treatment. Complete response is defined as the disappearance of all signs of cancer in response to treatment. Partial response is defined decrease in the size of target lesions by ≥ 50%, with no increase in the size of any lesion and no appearance of new lesions. Treated patients who do not have a 3-month evaluation will be classified as a non-response. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 3 months after radiation treatment
|
|
Time to progression rate
時間枠：Up to 24 months after radiation treatment
|
Local control will be defined as the number of days from end of radiation treatment until first local recurrence within 24 months post radiation treatment. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 24 months after radiation treatment
|
|
Patient reported quality of life
時間枠：Up to 3 months after radiation treatment
|
Patient reported quality of life will be measured using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, a 13-item questionnaire answered on a scale of 1-5 where 1=Not at all and 5=Very much. Treatment cycles are 5 days ±2 days (Arm 1) and 16 days ±2 days (Arm 2). |
Up to 3 months after radiation treatment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Brad S. Hoppe, MD, MPH、Mayo Clinic
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 (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
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。