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

PHASE3RECRUITING

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

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Study 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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

The primary tumor in the lung must be biopsy confirmed non-small cell lung cancer within 180 days prior to randomization.

Tumor ≤ 4 cm maximum diameter, including clinical stage IA and selected IB by PET/CT scan of the chest and upper abdomen performed within 180 days prior to randomization. Repeat imaging within 90 days prior to randomization is recommended for re-staging but is not required based on institutional norms.

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 within 180 days of randomization.

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 180 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 3.1.11 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

Major Criteria: FEV1 ≤ 50% predicted (pre-bronchodilator value), DLCO ≤ 50% predicted (pre-bronchodilator value)

Minor Criteria: Age ≥75, FEV1 51-60% predicted (pre-bronchodilator value), DLCO 51-60% predicted (pre-bronchodilator value), Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mm Hg) as estimated by echocardiography or right heart catheterization, Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by the patient for tangible or intangible reasons. The belief must be declared and documented in the medical record prior to randomization., Poor left ventricular function (defined as an ejection fraction of 40% or less), Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%, pCO2 > 45 mm Hg, Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3.

No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side. 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 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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2015-07-01

Primary completion: 2028-12-01

Study completion finish: 2028-12-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT02468024

Intervention or treatment

PROCEDURE: Lung Surgery

RADIATION: Radiation therapy

Conditions

• Non-Small Cell Lung Cancer

Image related to Non-Small Cell Lung Cancer

Condition: Non-Small Cell Lung Cancer
PROCEDURE: Lung Surgery and other drugs
Fitzroy, Victoria, Australia
Sponsor: University of Texas Southwestern Medical Center

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Find a site

Closest Location:

St. Vincent's/Peter Mac

Research sites nearby

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St. Vincent's/Peter Mac
Fitzroy, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Arm 1 lung surgery Sublobar Resection (SR)	PROCEDURE: Lung Surgery Sublobar Lung Resection
EXPERIMENTAL: Arm 2 radiation therapy Stereotactic Ablative Radiotherapy (SAbR)	RADIATION: Radiation therapy Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
overall survival	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).	3 years

Secondary outcome

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

Frequently Asked Questions

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References

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