Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

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

Details

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.

Keywords

Non-Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lung Surgery Radiation therapy

Eligibility

You can join if…

Open to people ages 18-99

  • 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.

You CAN'T join if...

  • 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).

Locations

  • UCSD accepting new patients
    La Jolla California 92023 United States
  • Intermountain Medical Center accepting new patients
    Salt Lake City Utah 84107 United States
  • Penrose Cancer Center accepting new patients
    Colorado Springs Colorado 80907 United States
  • University of Colorado/Memorial accepting new patients
    Aurora Colorado 80045 United States
  • Providence Health & Services/Oregon Clinic accepting new patients
    Portland Oregon 97213 United States
  • Swedish Cancer Institute accepting new patients
    Seattle Washington 98104 United States
  • Cardiothoracic and Vascular Surgeons accepting new patients
    Austin Texas 78756 United States
  • University of Texas Southwestern Medical Center accepting new patients
    Dallas Texas 75390 United States
  • University of Kansas Medical Center accepting new patients
    Kansas City Kansas 66160 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Texas Southwestern Medical Center
ID
NCT02468024
Phase
Phase 3
Study Type
Interventional
Last Updated
June 12, 2018