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

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ClinicalTrials.gov Identifier: NCT02136355
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute

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.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Radiation: Stereotactic Body Radiation Therapy plus Surgery Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Measuring the Integration of Stereotactic Radiotherapy Plus Surgery in Early Non-Small Cell Lung Cancer
Study Start Date : September 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection
Radiation: Stereotactic Body Radiation Therapy plus Surgery
Stereotactic body radiation therapy followed by surgical resection




Primary Outcome Measures :
  1. Tumor response [ Time Frame: 2.5 years ]
    Percentage of patients who exhibit a lack of viable tumor after surgical resection


Secondary Outcome Measures :
  1. 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)

  2. Tumor recurrence [ Time Frame: 7 years ]
    Time to local recurrence, regional recurrence, and distant recurrence of disease will be measured

  3. 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.

  4. Quality of life [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136355


Locations
Canada, Ontario
London Regional Cancer Program of the Lawson Health Research Institute
London, Ontario, Canada, N6A 4L6
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: David Palma, MD, PhD London Regional Cancer Program of the Lawson Health Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Palma, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02136355     History of Changes
Other Study ID Numbers: MISSILE NSCLC
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms