Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation
Phase III Randomized Study Testing Non-Inferiority of Short-Course Ultra-Hypofractionated Radiation (UHRT-5) Versus Standard Fractionation (RT-25) for Stage II-IIIB, Extremity, Resectable Soft Tissue Sarcoma
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVE:
I. To evaluate whether the incidence of local tumor recurrence at 2-years after randomization with short-course radiation is non-inferior to standard-course radiation among participants with high-risk, resectable soft tissue sarcoma.
SECONDARY OBJECTIVES:
I. To estimate and compare between arms the incidence of acute wound complications.
II. To estimate and compare between arms the incidence of late-term complications associated with radiation at 2-years post-surgery.
III. To estimate and compare between arms changes in physician-assessed functional outcome from pre-randomization to 12 and 24 months post surgery using the Musculoskeletal Tumor Society Scoring system.
IV. To estimate and compare between arms overall survival, progression-free survival, and distant-metastasis-free survival measured from randomization.
EXPLORATORY OBJECTIVES:
I. To estimate and compare between arms the incidence of local tumor recurrence at 2 years using a per-protocol analysis.
II. To estimate and compare between arms the incidence of delayed wound healing.
III. To report the type of surgical resection by treatment arm, including limb-salvage versus amputation and margin status (R0, R1, or R2).
IV. To describe the use of supportive therapy medications given with radiation therapy separately by treatment arm.
V. To describe the use of adjuvant therapy post-surgery separately by treatment arm.
BANKING OBJECTIVE:
I. To bank tissue specimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo RT-25 with 3D CRT or IMRT once daily (QD) for up to 5 fractions per week for 25 fractions over a minimum of 32 calendar days and maximum of 49 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo magnetic resonance imaging (MRI), computed tomography (CT), and blood sample collection throughout the study.
ARM 2: Patients undergo UHRT-5 with 3D CRT or IMRT QD for up to 5 fractions per week for 5 fractions over a minimum of 5 calendar days and maximum of 14 days in the absence of disease progression or unacceptable toxicity. Starting 22-56 calendar days after radiation, patients undergo surgical resection. Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 4 months, every 6 months after surgery for up to 5 years, and then annually for up to 10 years after randomization.
研究の種類
入学 (推定)
段階
- フェーズ 3
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer [AJCC] 8th edition) soft tissue sarcoma is required
- Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease > 1cm in longest dimension (stage II-IIIB)
Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and feet
- Participants with primary sites of trunk, head, neck, or intra-abdominal, intrapelvic, or retroperitoneal region are not eligible
- Participants with extension of the primary tumor into adjacent regions (e.g. torso, hands, feet) are eligible
- Participants must have an MRI of the primary site within 90 days prior to randomization. The MRI field of view must contain the entirety of the tumor (may be accomplished with multiple MRI scans). MRI must contain axial acquired T1 weighted with fat suppression, T1 weighted sequence with gadolinium contrast with fat suppression, and T2 weighted fat suppression sequence
Participants must have no evidence of metastatic disease by CT imaging of the chest (or positron emission tomography [PET] CT), within 28 days before randomization
- Given the lack of specificity of chest CT, pulmonary nodule(s) ≤ 5 mm without a histological diagnosis are not exclusionary
- Participants with pulmonary nodule(s) measuring 6-10 mm on chest CT are eligible if the nodules appear stable compared to prior chest imaging from at least 6 months ago, or if an fludeoxyglucose F-18 (18FDG)-PET scan indicates that the nodules are unlikely to be metastatic disease
- Pulmonary nodules > 10 mm should be considered metastatic unless proven otherwise by biopsy/resection or stable appearance for at least 6 months on imaging
- Participants must not have fungating tumor. (i.e., tumor breakthrough of skin)
- Participants must not have myxoid liposarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, gastrointestinal stromal tumor, osteosarcoma, neurotrophic tyrosine receptor kinase (NTRK)-rearranged spindle cell neoplasm, desmoplastic small round cell tumor, Ewing sarcoma, or sarcoma arising from bone
- Participants must not have known brain metastases. Brain imaging studies are not required for eligibility if the participant has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease
- Participants must have been evaluated by a surgeon, and it must have been determined that they are a good candidate for a limb salvage resection with an expectation of negative margins, within 35 days prior to randomization. Anticipated positive margins on fixed critical structures are allowed
- Participants must not have had prior treatment for the current tumor (systemic therapy, radiation, or complete surgical resection)
- Participants must not have had prior radiation to the anatomical site
- Participants must be ≥ 18 years old at the time of randomization
- Participants must have Zubrod performance status of 0-2
- Participants must have medical history and physical exam within 28 days prior to randomization. History and physical examination must include a description of the location of the tumor, including lateralization and extremity
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
- Participants must not have uncontrolled intercurrent illnesses or any other significant condition(s) that would make this protocol unreasonably hazardous
- Participants with a history human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
- Participants registered by sites located in the United States only must be offered the opportunity to participate in specimen banking
NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
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：Arm 1 (RT-25)
Patients undergo RT-25 with 3D CRT or IMRT QD for up to 5 fractions per week for 25 fractions over a minimum of 32 calendar days and maximum of 49 days in the absence of disease progression or unacceptable toxicity.
Starting 22-56 calendar days after radiation, patients undergo surgical resection.
Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.
|
MRIを受ける
他の名前：
CTを受ける
他の名前：
採血を受ける
他の名前：
外科的切除を受ける
他の名前：
Undergo RT-25 with 3D-CRT
他の名前：
Undergo UHRT-5 with 3D CRT
他の名前：
Undergo RT-25 with IMRT
他の名前：
Undergo UHRT-5 with IMRT
他の名前：
|
|
実験的：Arm 2 (UHRT-5)
Patients undergo UHRT-5 with 3D CRT or IMRT QD for up to 5 fractions per week for 5 fractions over a minimum of 5 calendar days and maximum of 14 days in the absence of disease progression or unacceptable toxicity.
Starting 22-56 calendar days after radiation, patients undergo surgical resection.
Additionally, patients undergo MRI, CT, and blood sample collection throughout the study.
|
MRIを受ける
他の名前：
CTを受ける
他の名前：
採血を受ける
他の名前：
外科的切除を受ける
他の名前：
Undergo RT-25 with 3D-CRT
他の名前：
Undergo UHRT-5 with 3D CRT
他の名前：
Undergo RT-25 with IMRT
他の名前：
Undergo UHRT-5 with IMRT
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 |
|---|---|---|
|
Local tumor recurrence rate
時間枠：At 2 years
|
Cumulative incidence of local tumor recurrence will be estimated non-parametrically with death from any cause analyzed as a competing risk.
2-year estimates of local tumor recurrence and standard errors will be calculated and used to calculate a one-sided 95% confidence internal for the difference in 2-year local tumor recurrence rates.
|
At 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 acute wound complications
時間枠：Up to 4 months after surgery
|
Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.
|
Up to 4 months after surgery
|
|
Incidence of late-term complications associated with radiation
時間枠：Up to 2 years post-surgery
|
Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.
|
Up to 2 years post-surgery
|
|
Changes in physician-assessed functional outcome
時間枠：From pre-randomization up to 24 months post-surgery
|
Will be evaluated using the Musculoskeletal Tumor Society Scoring system.
|
From pre-randomization up to 24 months post-surgery
|
|
Overall survival
時間枠：From randomization up to 10 years
|
Will be estimated in each arm and compared using log-rank tests.
|
From randomization up to 10 years
|
|
Progression-free survival
時間枠：From randomization up to 10 years
|
Will be estimated in each arm and compared using log-rank tests.
|
From randomization up to 10 years
|
|
Distant-metastasis-free survival
時間枠：From randomization up to 10 years
|
Cumulative incidence will be estimated non-parametrically in each arm and compared using Gray's test.
|
From randomization up to 10 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of local tumor recurrence
時間枠：At 2 years
|
Will estimate and compare between arms using a per-protocol analysis and report with 95% confidence intervals.
Will be estimated non-parametrically in each arm based on observed reporting of events without pooling/harmonizing of event times and descriptively reported.
|
At 2 years
|
|
Incidence of delayed wound healing
時間枠：Up to 6 months post-surgery
|
Will estimate and compare between arms the incidence of delayed wound healing and report 95% confidence intervals and compare with Fisher's exact test.
|
Up to 6 months post-surgery
|
|
Type of surgical resection
時間枠：At time of surgery
|
Will report the type of surgical resection by treatment arm, including limb-salvage versus amputation and margin status with exact 95% confidence intervals.
|
At time of surgery
|
|
Use of supportive therapy medications given with radiation therapy
時間枠：Up to 10 years
|
Will describe the use of supportive therapy medications given with radiation therapy separately by treatment arm.
|
Up to 10 years
|
|
Use of adjuvant therapy post-surgery
時間枠：Up to 10 years
|
Will describe the use of adjuvant therapy post-surgery separately by treatment arm.
|
Up to 10 years
|
協力者と研究者
捜査官
- 主任研究者：Jeremy P Harris、SWOG Cancer Research Network
研究記録日
主要日程の研究
研究開始 (推定)
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
- S2505 (その他の識別子：CTEP)
- U10CA180888 (米国 NIH グラント/契約)
- NCI-2026-02587 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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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磁気共鳴画像の臨床試験
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Germans Trias i Pujol Hospital完了虚血性脳卒中 | 磁気共鳴画像 | 動脈閉塞 | CTSスペイン
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French Cardiology SocietyInstitut National de la Santé Et de la Recherche Médicale, France完了
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Istituto Oncologico Veneto IRCCSまだ募集していません
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VisionScope Technologies完了半月板の涙 | ルースボディ | 変形性関節症 | 関節または関節包の外傷アメリカ
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Medical Centre LeeuwardenUniversity of Groningen; LIMIS Development募集