Clinical trial · Interventional
A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
NCT02136355CI-TRIAL-00064533completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy plus Surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy plus Surgery
- description
- Stereotactic body radiation therapy followed by surgical resection
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy plus Surgery
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- 2.5 years
- description
- Percentage of patients who exhibit a lack of viable tumor after surgical resection
Secondary outcomes (4)
- measure
- Predictive value of imaging biomarkers
- timeFrame
- 2.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDYang 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. PMID 33441162
- DERIVEDPalma 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. PMID 30789648
- DERIVEDPalma 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. PMID 28129789