ステージ I ～ IV の胃 MALT リンパ腫患者の治療における超低線量放射線療法
胃MALTリンパ腫の根治的治療のための超低線量4 Gy放射線
This trial studies how well ultra low-dose radiation therapy works in treating patients with stage I-IV stomach mucosa-associated lymphoid tissue (MALT) lymphoma. Ultra low-dose radiation therapy may be able to kill tumor cells and shrink tumors while having fewer side effects in patients with MALT lymphoma.
調査の概要
詳細な説明
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of ultra-low dose 4 Gy gastric radiation, measured as complete gastric response at one year after 4 Gy treatment in patients with marginal zone lymphoma involving the stomach (mucosa-associated lymphoid tissue [MALT]).
SECONDARY OBJECTIVES:
I. To evaluate distant recurrence of marginal zone lymphoma at one year. II. To evaluate toxicity associated with gastric radiation therapy.
EXPLORATORY OBJECTIVES:
I. To determine if microbiome assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microbiome for patients who respond well and poorly to low dose radiation.
II. To determine if micro-ribonucleic acid (RNA) assessment can predict response to ultra-low dose radiation therapy and evaluate the differences in patient microRNA profiles for patients who respond well and poorly to low dose radiation.
III. To explore the role of magnetic resonance imaging (MRI) for staging gastric MALT lymphoma and for predicting response to ultra-low dose radiation therapy.
IV. To encourage optional co-enrollment on study PA18-0644 to facilitate collection and archiving of blood based biomarkers and microbiome samples for patients receiving ultra low dose radiation therapy.
OUTLINE:
Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician.
After completion of study treatment, patients are followed up every 3 months for up to 1 year.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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-
Texas
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Houston、Texas、アメリカ、77030
- M D Anderson Cancer 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
説明
Inclusion Criteria:
- Patients 18 years or older with stage I-IV MALT lymphoma involving the stomach. Other low grade lymphomas including follicular grade I/II and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible
- Patients must have biopsy-proven disease within the stomach. Patients with clinical and/or radiographic masses will have dimensions noted prior to therapy
- Patients must have H. pylori testing which is negative within 6 months prior to treatment
- Female patients of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin [hCG]) within 2 weeks of protocol entry
- Planned systemic therapy prior to, during, or after gastric radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of systemic therapy
- Patients must have the ability to give informed consent
- Necessary treatment with antibiotics for reasons unrelated to gastric lymphoma is permitted however the timing and nature of the treatment will be recorded
Exclusion Criteria:
- Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
- Patients with other histologic subtypes of low grade lymphoma (other than MALT) including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or follicular lymphoma
- Patients with bulky tumors > 10 cm in any dimension
- Patients with a history of prior radiation to the stomach if re-treatment would exceed known gastric or surrounding critical structure (e.g., bowel, spinal cord) tolerance
- Patients who are pregnant
- Patients with scleroderma are ineligible
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：なし
- 介入モデル：単一グループの割り当て
- 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：Treatment (low-dose radiation therapy)
Patients undergo low-dose radiation therapy over 2 fractions for 2 consecutive days in the absence of disease progression or unacceptable toxicity. Patients with stable or progressive disease at 12-16 weeks post-treatment, or persistent disease at 1 year may undergo higher-dose radiation therapy at the discretion of treating physician. |
Undergo ultra low-dose radiation
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 |
|---|---|---|
|
Complete gastric response
時間枠：Up to 1 year
|
The complete response rate at one year will be estimated along with 95% confidence intervals. |
Up to 1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Distant recurrence defined as disease progression outside of the stomach that was not present initially
時間枠：Up to 1 year
|
Distant recurrence rate at one year will be estimated along with 95% confidence intervals. |
Up to 1 year
|
|
Incidence of acute gastrointestinal toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03
時間枠：Up to 1 year
|
Toxicity data will be summarized by frequency tables. |
Up to 1 year
|
|
Incidence of chronic gastrointestinal toxicity graded according to CTCAE v. 4.03
時間枠：Up to 1 year
|
Toxicity data will be summarized by frequency tables. |
Up to 1 year
|
|
Time to local gastric event
時間枠：Up to 1 year
|
Will be estimated using the Kaplan-Meier method. |
Up to 1 year
|
|
Time to distant event
時間枠：Up to 1 year
|
Will be estimated using the Kaplan-Meier method. |
Up to 1 year
|
|
Tumor response
時間枠：Up to 1 year
|
The tumor responses will be summarized stratified by systemic treatments. |
Up to 1 year
|
協力者と研究者
捜査官
- 主任研究者：Jillian Gunther、M.D. Anderson Cancer Center
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
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