Clinical Trials /

JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer

NCT02468024

Description:

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
  • Official Title: JoLT-Ca A Randomized Phase III Study of Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) in High Risk Patients With Stage I Non-Small Cell Lung Cancer (NSCLC), The STABLE-MATES Trial

Clinical Trial IDs

  • ORG STUDY ID: STU 022015-069
  • NCT ID: NCT02468024

Conditions

  • Non-Small Cell Lung Cancer

Purpose

To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC

Detailed Description

      Stereotactic Ablative Radiotherapy has been shown in single institution phase II and matched
      cohort studies to be effective at controlling primary early lung cancer. Recent pooled
      analysis of both the STARS and ROSEL randomized trials comparing SABR versus lobectomy have
      shown a significantly improved 3-year survival with SABR, giving further impetus for
      successful completion of a randomized trial .

      Pre-randomized trial- Patients will be screened and pre-randomized to either SR or SAbR.
      Informed consent will be obtained after patients are made aware of the randomized
      assignment. Despite pre-randomization prior to consent, patients maintain their right to
      accept or decline any/all study activities. Only consenting patients will be allowed to
      participate in study activities, including observation after either randomized treatments or
      observation after standard of care treatment, while those declining consent will be managed
      by their physician(s) off study.Patients will be accrued and followed for a minimum of
      2-years after treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1 lung surgeryActive ComparatorSublobar Resection (SR)
    Arm 2 radiation therapyExperimentalStereotactic Ablative Radiotherapy (SAbR)

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Age > 18 years.
      
                -  ECOG performance status (PS) 0, 1, or 2.
      
                -  Radiographic findings consistent with non-small cell lung cancer, including lesions
                   with ground glass opacities with a solid component of 50% or greater. Those with
                   ground glass opacities and <50% solid component will be excluded.
      
                -  Biopsy confirmed non-small cell lung cancer.
      
                -  Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT
                   scan of the chest and upper abdomen performed within 60 days prior to registration.
      
                -  All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis
                   dimension on CT scan and/or positive on PET scan) confirmed negative for involvement
                   with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy
                   EUS/EBUS guided needle aspiration, CT-guided, video-assisted thoracoscopic or open
                   lymph node biopsy.
      
                -  Tumor verified by a thoracic surgeon to be in a location that will permit sublobar
                   resection.
      
                -  Tumor located peripherally within the lung. NOTE: Peripheral is defined as not
                   touching any surface within 2 cm of the proximal bronchial tree in all directions.
                   See below. Patients with non-peripheral (central) tumors are NOT eligible.
      
                -  No evidence of distant metastases.
      
                -  Availability of pulmonary function tests (PFTs - spirometry, DLCO, +/- arterial blood
                   gases) within 90 days prior to registration. Patients with tracheotomy, etc, who are
                   physically unable to perform PFTs (and therefore cannot be tested for the Major
                   criteria in 3.1.10 below) are potentially still eligible if a study credentialed
                   thoracic surgeon documents that the patient's health characteristics would otherwise
                   have been acceptable for eligibility as a high risk but nonetheless operable patient
                   (in particular be eligible for sublobar resection).
      
                -  Patient at high-risk for surgery by meeting a minimum of one major criteria or two
                   minor criteria
      
                -  No prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of
                   treatment for head and neck, breast, or other non-thoracic cancer is permitted so
                   long as possible radiation fields would not overlap. Previous chemotherapy or
                   surgical resection specifically for the lung cancer being treated on this protocol is
                   NOT permitted. No prior lung resection on the ipsilateral side.
      
                -  Non-pregnant and non-lactating. Women of child-bearing potential must have a negative
                   urine or serum pregnancy test within 60 days prior to registration. Peri-menopausal
                   women must be amenorrheic > 12 months prior to registration to be considered not of
                   childbearing potential.
      
                -  No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration
                   (exceptions: non-melanoma skin cancer, in-situ cancers).
      
                -  Ability to understand and the willingness to sign a written informed consent.
      
              Exclusion Criteria:
      
                -  evidence of distant metastases
      
                -  prior intra-thoracic radiation therapy. NOTE: Previous radiotherapy as part of
                   treatment for head and neck, breast, or other non-thoracic cancer is permitted so
                   long as possible radiation fields would not overlap. Previous chemotherapy or
                   surgical resection specifically for the lung cancer being treated on this protocol is
                   NOT permitted. No prior lung resection on the ipsilateral side.
      
                -  pregnant and lactating women
      
                -  prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration
                   (exceptions: non-melanoma skin cancer, in-situ cancers).
            
      Maximum Eligible Age:99 Years
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:overall survival
      Time Frame:3 years
      Safety Issue:
      Description:To test the hypothesis that the 3-year overall survival in high risk operable patients with Stage I NSCLC is greater in patient who undergo SAbR as compared to standard sublobar resection (SR).

      Secondary Outcome Measures

      Measure:progression free survival
      Time Frame:5 years
      Safety Issue:
      Description:survival at 5-years for Stage I NSCLC who undergo SR or SAbR.
      Measure:toxicity as assessed toxicity using the Common Toxicity Criteria
      Time Frame:3 years
      Safety Issue:
      Description:toxicity using the Common Toxicity Criteria

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:University of Texas Southwestern Medical Center

      Last Updated

      July 14, 2016