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Compares treatment options for Non-Small Cell Lung Cancer
Official title JoLT-Ca Sublobar Resection (SR) Versus Stereotactic Ablative Radiotherapy (SAbR) for Lung Cancer
ClinicalTrials.gov ID: NCT02468024
What this study is testing
- What it's testing
- To Determine if SAbR improves survival over SR in High Risk Operable Stage I NSCLC
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1.0 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with...
- FEV1 ≤ 50% predicted (pre-bronchodilator value)
- DLCO ≤ 50% predicted (pre-bronchodilator value)
- Study credentialed thoracic surgeon believes the patient is potentially operable but that a lobectomy or pneumonectomy would be poorly tolerated by...
- Minor Criteria
You likely can't join if
- 2.1 Age \<18
- 2.2 ECOG/Zubrod performance status (PS) greater than 3.
- 2.3 Radiographic findings with ground glass opacities and less than 50% solid component will be excluded.
- 2.4 The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization.
- 2.5 Tumor \> 5 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the...
- 2.6 Lymph node biopsy greater than 180 days prior to randomization.
See the full eligibility criteria
- 1.0 1.1 Age \> 18 years. 1.2 ECOG/Zubrod performance status (PS) 0, 1, or 2 (reference Appendix C). 1.3 Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities...
- FEV1 ≤ 50% predicted (pre-bronchodilator value)
- DLCO ≤ 50% predicted (pre-bronchodilator value)
- 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...
- 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
- 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. 1.12 No prior intra-thoracic radiation therapy for previously identified intra-thoracic primary tumor (e.g. previous lung cancer) on the ipsilateral side...
- 2.1 Age \<18
- 2.2 ECOG/Zubrod performance status (PS) greater than 3.
- 2.3 Radiographic findings with ground glass opacities and less than 50% solid component will be excluded.
- 2.4 The primary tumor in the lung, biopsy confirmed non-small cell lung cancer greater than 180 days prior to randomization.
- 2.5 Tumor \> 5 cm maximum diameter, including clinical stage IA and selected IB by PET or PET integrated with a simultaneous CT scan (PET-CT) of the chest and upper abdomen and/or performed greater than 180 days prior...
- 2.6 Lymph node biopsy greater than 180 days prior to randomization.
- 2.7 Thoracic surgeon confirms unable to remove tumor with sublobar resection.
- 2.8 Tumor located non-peripheral (central) region of lung (see bronchial tree diagram in 3.1.8).
- 2.9 Evidence of distant metastases.
- 2.10 Pulmonary function test (PFT - spirometry, DLCO, +/- arterial blood gases) greater than 180 days prior to registration. Patients physically unable to perform PFT's, such as patients with tracheotomy, that do not...
- 2.11 Patients that do not meet either Major criteria or Minor criteria.
- 2.12 Prior intra-thoracic radiation therapy on ipsilateral side. Radiotherapy to the contralateral lung completed less than 3 years prior to randomization, with radiation field overlap.
- 2.13 Prior chemotherapy, radiotherapy, or surgical resection specifically for the lung cancer being treated on this protocol.
- 2.14 Prior lung resection on the ipsilateral side.
- 2.15 Pregnant and lactating women.
- 2.16 Prior invasive malignancy and less than 3 years disease free prior to registration (unless non-melanoma skin cancer, in-situ cancers).
- 2.17 Unable to understand and/ or sign a written informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Aurora, Colorado, United States
- Colorado Springs, Colorado, United States
- Boca Raton, Florida, United States
- Savannah, Georgia, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Annapolis, Maryland, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- Neptune City, New Jersey, United States
- New York, New York, United States
- Syracuse, New York, United States
- Chapel Hill, North Carolina, United States
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Aurora, Colorado, United States; Colorado Springs, Colorado, United States; Boca Raton, Florida, United States; Savannah, Georgia, United States; Iowa City, Iowa, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.