Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors
Multicenter, Randomized Phase II Trial on Palliative Radiation With or Without Spatially Fractionated Radiotherapy Boost for Unresectable Bulky Malignancies
This clinical trial evaluates whether adding spatially fractionated radiation therapy (SFRT) to standard palliative external beam radiation therapy (EBRT) improves disease-related symptoms in patients with solid tumors that cannot be removed by surgery (unresectable). SFRT, originally termed GRID therapy, is a radiation therapy technique designed to deliver a highly uneven dose of radiation to a tumor. This is achieved by using a grid-like pattern, where isolated regions receive high doses, while the spaces between experience significantly lower doses. This method allows for a greater total dose to be delivered to the tumor while potentially reducing damage to surrounding healthy tissues. EBRT is a type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body. Adding SFRT to standard palliative EBRT may improve disease-related symptoms such as pain, difficulty breathing, bleeding, or difficulty swallowing in patients with unresectable solid tumors.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
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：
- Diego A. Santos Toesca, MD
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic in Rochester
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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：
- Meng X. Welliver, 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
Inclusion Criteria:
- Histologically proven primary or metastatic solid malignant tumors from any histologic subtype
- Measurable primary or metastatic bulky tumor defined as tumor > 5 cm in largest dimension not eligible for surgical resection or not an ideal candidate for alternative local therapies, e.g., cryoablation, etc.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 assessed within 30 days of enrollment
- Estimated life expectancy > 3 months, as judged by treating clinician
- Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time limits
- Patients must be able to start treatment (radiation) within 60 days of study registration
- Patients must be at least 15 years old
- A minimum most prominent symptom intensity score reported by the patient of >= 5 on an 11-point symptom intensity scale (item 4.3.2), clearly related to the target lesion, within one the following: pain, dyspnea, hemorrhage, or dysphagia
Exclusion Criteria:
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Prior RT to the current target site < 3 months from randomization
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Intracranial invasion by the proposed tumor target or tumor target intertwined with bowel loops
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Concurrent systemic therapy (e.g., chemotherapy, immunotherapy) during RT delivery will not be an exclusion condition
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Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed), for patients whose target tumor is in the pelvis
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Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted for this study
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History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
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On a transplant list
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Any of the following are excluded because this study involves ionizing radiation:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential who are unwilling to employ adequate birth control measures will be asked to stay on adequate forms of birth control until study intervention (therapy) is finished
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 |
|---|---|
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実験的：Group I (SFRT, EBRT)
Patients undergo a single fraction of SFRT. Starting 1-3 days after SFRT, patients undergo standard palliative EBRT in a dose regimen determined by the treating physician. |
Ancillary studies Ancillary studies Undergo standard palliative EBRT
他の名前：
Undergo SFRT
他の名前：
|
|
アクティブコンパレータ：Group II (EBRT)
Patients undergo standard palliative EBRT in a dose regimen determined by the treating physician. |
Ancillary studies Ancillary studies Undergo standard palliative EBRT
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 |
|---|---|---|
|
Response at 1 month - Patient-reported Impression of Change
時間枠：Baseline to 1 month follow-up
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Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 1 month after completing treatment. |
Baseline to 1 month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Patient-reported Most Prominent Symptom Intensity
時間枠：Baseline to 1 month follow-up
|
Participants will record the severity of the most prominent symptom related to the target lesion (e.g., pain, dyspnea, hemorrhage, dysphagia) using an 11-point Likert scale ranging from 0 (none) to 10 (unbearable). A between-group comparison of the magnitude of the severity scores will be made. |
Baseline to 1 month follow-up
|
|
Response at 3 months - Patient-reported Impression of Change
時間枠：At 3 month follow-up
|
Participants rate the most prominent symptom related to the target lesion to be treated on a 7-point scale ranging from -3 (very much worse) to +3 (very much better). Response will be reported as a binary yes/no, defined as a patient reporting that the symptom is moderately better or very much better 3 months after completing treatment. |
At 3 month follow-up
|
|
Radiographic tumor response
時間枠：At 3 month follow-up
|
Radiographic tumor response at 3 months post-treatment will be assessed by a modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Radiographic tumor response will be coded as a 1 if the patient meets the complete response (CR) or partial response (PR) modified RECIST criteria and 0 otherwise. Per the modified RECIST criteria, CR will be defined as disappearance of the target lesion, PR will be defined as ≥30% decrease in longest diameter (LD) of target lesion as compared to baseline measurement, Progressive Disease (PD) will be defined as ≥20% increase in LD of target lesion as compared to baseline measurement, and Stable Disease (SD) will be defined as not meeting the criteria for CR, PR, or PD. |
At 3 month follow-up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Diego Augusto Santos Toesca, MD、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
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
- GMROA2481
- NCI-2026-06455 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 25-005298 (その他の識別子：Mayo Clinic Institutional Review Board)
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
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