The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis.
With the advent of effective neoadjuvant therapies, many patients with Stage II or III lung cancer are being downstaged to Stage I. Recent studies have shown that sublobar resections, especially segmentectomy, offer superior long-term survival and quality of life for patients with Stage I cancer. However, aside from isolated cases, the safety and feasibility of performing segmentectomy on patients who were initially diagnosed with advanced-stage cancer but were later downstaged to Stage I remain unexplored. Thus, our hypothesis is that segmentectomy can be safely executed in these downstaged Stage I patients after neoadjuvant therapy, without necessitating a conversion to lobectomy due to technical complications. Both segmentectomy and lobectomy are considered standard-of-care lung resection procedures. Recent randomized clinical trials have demonstrated high rates of pathological downstaging for locally advanced lung cancer treated with neoadjuvant chemoimmunotherapy with R0 resection rates of 83.2% to 77.8% in recent historical controls. Other recent trials demonstrated that high-quality segmentectomy is associated with improved overall survival and is now standard-of-care for early-stage lung cancer with small tumor sizes. Given these findings, the logical next step is to determine if the benefits of high-quality segmentectomy may be extended to an increasingly common clinical scenario where locally advanced lung cancers are downstaged to small tumor size after induction therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A segmentectomy is a surgical procedure to remove a segment of the lung. This surgery will be done on patients who have completed neoadjuvant therapy for diagnosis of Non-Small Cell Lung Cancer.
Northwestern University
Chicago, Illinois, United States
RECRUITINGNumber of participants with Segmentectomy and R0 on final pathology
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). To address the primary objective, the proportion of patients who receive high-quality segmentectomy will be determined immediately at the end of the operation and R0 rates on final pathology will be collected after the surgical operation when pathological reports are completed.
Time frame: Up to 48 hours after date of surgical resection
R0 resection rates - on final pathology (post-surgery) if converted to lobectomy
The proportion of patients who received lobectomy with R0 resection on final pathology (post-surgery).
Time frame: Up to 48 hours after date of surgical resection
Ability to complete the intended procedure (sublobar anatomic resection)
The proportion of patients with completion of the intended procedure (sublobar anatomic resection) based on the extent of surgical resection immediately at the end of the operation
Time frame: Up to 24 hours after date of surgical resection
Conversion to lobectomy in a separate operation from sublobar anatomic resection
The proportion of patients who were converted to lobectomy during the operation or within six weeks after the operation for patients who undergo revision.
Time frame: Up to 6 weeks after date of surgical resection
Safety, measured as perioperative outcomes (Post-operative length of stay)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative length-of-stay): • Post-operative length of stay defined from the date of surgery until hospital discharge. -Outcome measured in number of days
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Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (post-operative discharge destination)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative discharge destination) • Post-operative discharge destination defined as including: i. Home ii. Extended Care/ Transitional Care Unit/ Rehab iii. Other Hospital iv. Nursing Home v. Hospice vi. Other vii. Expired
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (time to chest tube removal)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (time to chest tube removal) -Outcome measured as number of days from date of surgical resection to time of chest tube removal
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (blood transfusion requirements)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (blood transfusion requirements) -Outcome measured as number of units blood transfused, if required
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day unplanned readmission)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day unplanned readmission) -Outcome measured as number of days if unplanned readmission required after date of discharge following surgical resection and reasoning for readmission
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day morbidity)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day morbidity) -Outcome measured as status of participant at 30 days post-discharge from surgical resection procedure (alive or deceased)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day mortality)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day mortality) -Outcome measured as date of death within 30 days following discharge from surgical resection procedure
Time frame: Up to 30 days after date of surgical resection
Change in pre-operative FEV1 (forced expiratory volume at one second) at 3 and 6 months for lobectomy and sublobar anatomic resection
Changes in FEV1 pulmonary function from baseline to 3 and 6 months following lung resection for patients who receive sublobar anatomic resection or are converted to lobectomy. FEV1 will be measured using pulmonary function tests and expressed as % of expected value. Changes in FEV1 measured at baseline and at 3 and 6 months post-surgery
Time frame: Prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)