None listed
Conditions
Brief summary
Lobectomy (or removal of one of the lobes of the lung) is the standard operation for lung cancer that is amenable to surgery. For patients with insufficient breathing reserve, a sublobar resection (segmentectomy or wedge resection) can be offered as it involves the removal of much less lung. The question that surgeons do not know the answer to is how much lung needs to be removed to completely clear around a small lung cancer at the edge of the lung. It may or may not require the removal of the whole lobe, and this study will determine whether a sublobar resection is as good at controlling the cancer as a lobectomy. This is similar to studies in breast cancer that showed that the whole breast did bot have to be removed to control a small breast cancer.
Interventions
Sublobar resection (removal of less than one lobe of lung) consists of either segmentectomy or wedge resection of lung.
Segmentectomy refers to identifying and cutting the specific blood supply and airway to the particular segment of the lobe of lung containing the lung cancer. The procedure takes 2-3 hours.
Wedge resection refers to calculating a margin of normal tissue that allows full removal of the cancer, then removing that from the lobe of the lung using a cutting stapler. The procedure t
Sublobar resection (removal of less than one lobe of lung) consists of either segmentectomy or wedge resection of lung. Segmentectomy refers to identifying and cutting the specific blood supply and airway to the particular segment of the lobe of lung containing the lung cancer. The procedure takes 2-3 hours. Wedge resection refers to calculating a margin of normal tissue that allows full removal of the cancer, then removing that from the lobe of the lung using a cutting stapler. The procedure takes about one hour. Sublobar resection can be done through a thoracotomy (large cut on the side of the chest) or with Video-Assisted Thoracic Surgery (VATS), which uses small incisions and a telescope to achieve the same internal operation.
Sponsors
The National Cancer Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Suspected or proven non-small cell lung cancer (NSCLC), meeting both preoperative and intraoperative criteria: Preoperative criteria - Peripheral lung nodule = 2 cm by computed tomography (CT scan) AND Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan AND Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy) AND No pure ground opacities or pathologically confirmed N1 or N2 disease Intraoperative criteria - Histologically confirmed NSCLC AND Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side (Levels 4 and 7 nodes may be sampled up to 6 weeks preoperatively by mediastinoscopy, endobronchial ultrasound (EBUS), and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration)
Exclusion criteria
Evidence of locally advanced or metastatic disease Prior chemotherapy or radiotherapy for this malignancy Eastern Cooperative Oncology Group (ECOG) Performance status > 2 Any other malignancy within the past 3 years except for non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
Outcome results
None listed