Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18 - 75
Clinical summary
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.
Conditions
This trial is treating people with Non-Small Cell Lung Cancer (stage IA)
Eligibility
Inclusion
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
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
Inclusion
- Your cancer has not spread to other parts of the body (localised).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Cancer and Leukemia Group B
Scientific Title
A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection for Small Peripheral Non-Small Cell Lung Cancer (Other IDs: CDR0000555324, CALGB-140503, ECOG-40503).
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