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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02136355
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : February 26, 2021
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 13, 2014
Last Update Posted Date February 26, 2021
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
Tumor response [ Time Frame: 2.5 years ]
Percentage of patients who exhibit a lack of viable tumor after surgical resection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2014)
  • Predictive value of imaging biomarkers [ Time Frame: 2.5 years ]
    Predictive value of novel imaging biomarkers compared to pathologic outcome (complete response or non-complete response to treatment)
  • Tumor recurrence [ Time Frame: 7 years ]
    Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured
  • Toxicity of the combined approach of SABR + surgery [ Time Frame: 7 years ]
    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.
  • Quality of life [ Time Frame: 7 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE Radiation: Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
Study Arms  ICMJE Experimental: Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
Intervention: Radiation: Stereotactic Body Radiation Therapy plus Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02136355
Other Study ID Numbers  ICMJE MISSILE NSCLC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Palma, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Palma, MD, PhD London Regional Cancer Program of the Lawson Health Research Institute
PRS Account Lawson Health Research Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP