A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer

NCT02136355 | Completed DMC

• 1 other identifier: MISSILE NSCLC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Percentage of patients who exhibit a lack of viable tumor after surgical resection

  2.5 years

Secondary Outcomes (4)

• Predictive value of imaging biomarkers

  2.5 years

• Tumor recurrence

  7 years

• Toxicity of the combined approach of SABR + surgery

  7 years

• Quality of life measures , including physical well-being, functional well-being, and lung-cancer subscale questions

  7 years

Study Arms (1)

Stereotactic Body Radiation Therapy plus Surgery

EXPERIMENTAL

Stereotactic body radiation therapy followed by surgical resection

Radiation: Stereotactic Body Radiation Therapy plus Surgery

Interventions

Stereotactic Body Radiation Therapy plus Surgery RADIATION

Stereotactic body radiation therapy followed by surgical resection

Stereotactic Body Radiation Therapy plus Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Regional Cancer Program of the Lawson Health Research Institute

London, Ontario, N6A 4L6, Canada

Location

Related Publications (3)

• 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.

  PMID: 33441162 DERIVED

• 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.

  PMID: 30789648 DERIVED

• 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.

  PMID: 28129789 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Investigative Techniques

Study Officials

• David Palma, MD, PhD

  London Regional Cancer Program of the Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 13, 2014
• Study Start: September 1, 2014
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

CA (1)