Non-Small Cell Lung Cancer study: Lung Surgery vs Radiation therapy
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
- This study aims to find out if a specific type of radiation therapy improves survival compared to surgery for people with early-stage lung cancer who are at higher risk.
- Who it's for
- The study is looking for people with early-stage non-small cell lung cancer who are considered high-risk for surgery.
- What's involved
- Participants will receive either a partial lung removal surgery or focused radiation therapy, along with regular check-ups and tests to monitor their health.
- Time commitment
- The study involves regular visits over time to track survival and health outcomes, though the exact duration is not specified in the provided text.
- 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).
- FEV1 ≤ 50% predicted (pre-bronchodilator value)
- DLCO ≤ 50% predicted (pre-bronchodilator value)
- Minor Criteria
- Age ≥75
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).
- 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
- 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.
- 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 is enrolling
- Savannah, Georgia, United States
- Neptune City, New Jersey, United States
- Syracuse, New York, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Fitzroy, Melbourne, Australia
- Fitzroy, Victoria, Australia
- Geelong, Victoria, Australia
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- London, Ontario, Canada, Canada
- Montreal, Quebec, Canada
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, but 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?
This study is enrolling now at Savannah, Georgia, United States; Neptune City, New Jersey, United States; Syracuse, New York, United States; Pittsburgh, Pennsylvania, United States; Dallas, Texas, United States; Fitzroy, Melbourne, Australia and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.