A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Stereotactic ablative radiotherapy (SABR) is a new radiation treatment that delivers high-dose, precise radiation to small tumors in 1-3 weeks of treatment.
The study combines SABR and surgery to treat non-small cell lung cancer. SABR will be done first, with surgery done approximately 10 weeks later. There will be some extra imaging done before and after the SABR.
The purpose of this study is to determine how effective SABR is in killing the cancer cells, and if SABR can help make surgery more effective.
연구 개요
상세 설명
The advent of stereotactic ablative radiotherapy (SABR) has provided a novel, promising treatment for patients with early-stage non-small cell lung cancer. SABR uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy.
The use of SABR as neoadjuvant therapy prior to surgery may provide a novel therapeutic opportunity. In oncology, the use of neoadjuvant radiotherapy or chemoradiotherapy prior to surgery has become widespread for several types of cancer, and in many instances improves local control over and/or survival compared to surgery alone. Neoadjuvant radiotherapy provides several theoretical advantages, including potentially decreasing the rate of positive margins, decreasing the size of the required resection, or by sterilizing the tumor to avoid seeding of circulating tumor cells during surgery. Although radiologic outcomes after SABR illustrate local control rates of approximately 90% in many studies, the presence of residual post-treatment fibrosis may confound this assessment of recurrence.
The goal of this study is to evaluate a novel treatment approach: the combination of neoadjuvant SABR followed by surgical resection in patients with T1T2N0 non-small cell lung cancer, in order to measure the true pathologic rates of local control after SABR, to develop new imaging biomarkers or response, and to assess clinical outcomes, including toxicity, relapse patterns, and survival.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 4L6
- London Regional Cancer Program of the Lawson Health Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 or older
- Willing to provide informed consent
- Histologically confirmed non-small cell lung cancer
- Tumor stage T1 or T2a (less than or equal to 5 cm)
- No evidence of nodal disease (N0)
- No evidence of distant metastases (M0)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy > 6 months
- Adequate forced expiratory volume at one second (FEV1), defined as a predicted post-operative FEV1 of 30% or greater
Exclusion Criteria:
- Serious medical comorbidities or other contraindications to radiotherapy or surgery
- Prior history of lung cancer within 5 years
- Prior thoracic radiation at any time
- Inability to attend full course of radiotherapy, surgery, or follow-up visits
- Contrast allergy
- Pregnant or lactating women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
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Stereotactic body radiation therapy followed by surgical resection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tumor response
기간: 2.5 years
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Percentage of patients who exhibit a lack of viable tumor after surgical resection
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2.5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Predictive value of imaging biomarkers
기간: 2.5 years
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Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment)
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2.5 years
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Tumor recurrence
기간: 7 years
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Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
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7 years
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Toxicity of the combined approach of SABR + surgery
기간: 7 years
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Toxicity of the combined approach of SABR plus surgical resection will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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7 years
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Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions
기간: 7 years
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The FACT-TOI is a summary score derived from the FACT-L and is composed of 21 items, including physical well-being, functional well-being, and lung-cancer subscale questions
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7 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: David Palma, MD, PhD, London Regional Cancer Program of the Lawson Health Research Institute
간행물 및 유용한 링크
일반 간행물
- Yang DM, Palma DA, Kwan K, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko BP, Laba J, Gaede S, Warner A, Inculet R, Lee TY. Predicting pathological complete response (pCR) after stereotactic ablative radiation therapy (SABR) of lung cancer using quantitative dynamic [18F]FDG PET and CT perfusion: a prospective exploratory clinical study. Radiat Oncol. 2021 Jan 13;16(1):11. doi: 10.1186/s13014-021-01747-z.
- Palma DA, Nguyen TK, Louie AV, Malthaner R, Fortin D, Rodrigues GB, Yaremko B, Laba J, Kwan K, Gaede S, Lee T, Ward A, Warner A, Inculet R. Measuring the Integration of Stereotactic Ablative Radiotherapy Plus Surgery for Early-Stage Non-Small Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2019 May 1;5(5):681-688. doi: 10.1001/jamaoncol.2018.6993.
- Palma DA, Nguyen TK, Kwan K, Gaede S, Landis M, Malthaner R, Fortin D, Louie AV, Frechette E, Rodrigues GB, Yaremko B, Yu E, Dar AR, Lee TY, Gratton A, Warner A, Ward A, Inculet R. Short report: interim safety results for a phase II trial measuring the integration of stereotactic ablative radiotherapy (SABR) plus surgery for early stage non-small cell lung cancer (MISSILE-NSCLC). Radiat Oncol. 2017 Jan 27;12(1):30. doi: 10.1186/s13014-017-0770-7.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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