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Respiratory Tract (Lung and Bronchial) Diseases

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Adenocarcinoma

Adenocarcinoma of Lung

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma in Situ

Lung Adenocarcinoma

Sublobar resection is performed for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section

Sublobar Resection includes segmentectomy and wedge resection

Sublobar Resection

Chaoqiang Deng

Chen Haiquan, MD

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1019. The goal of this clinical trial is to confirm the therapeutic effect of sublobar resection for AIS/MIA diagnosed by intraoperative frozen section.

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)

Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section: a Single-arm, Multi-center, Phase III Trial

The event is defined as the tumor recurrence.

The event is defined as the death due to any causes.

Fudan University

Director in the Department of Thoracic Surgery, FUSCC

Lung Diseases

Respiratory Tract Diseases

Sublobar resection

lobectomy

Jang-Ming Lee

Pei-Weng Yang

Lee Jang-Ming

A multi-center prospective randomized trial in Taiwan to investigate whether sublobar resection, as compared to lobectomy, can offer equivalent clinical results to treat early non-small cell lung cancer.

Background: Lung cancer has become an important disease threatening the public health world-wide. Surgical resection is the standard of care for treating non-small cell lung cancer in early stage. For decades, pulmonary lobectomy with lymph node dissection remains the gold standard of surgical approach. Pulmonary sublobar resection with pulmonary wedge resection or segmentectomy was reserved for the patients with high surgical risk, who were unsuitable for radical surgical resection. Pulmonary sublobar resection for tumor less than three centimeter was demonstrated to associated with higher risk of tumor recurrence or worsening survival outcome as compared to that done by lobectomy. 1 However, these data was which was not necessarily applicable to patients with early lung cancer with tumor of smaller size which was more frequently detected with the health screening test by CT scan in general population now. Although several retrospective studies has demonstrated that sublobar resection can offer a similar survival outcome after surgery as compared to that done by standard lobectomy once the tumor was smaller than two centimeter 2, there is still no consensus about the role of sublobar resection for these small early lung cancer. In general, there are several factors associating with higher risk of local recurrence which should be avoided for sublobar resection, including resection margin less than 2 cm or less than the diameter of the tumor itself 3, more obvious speculation in CT image or central location which makes it difficult to obtain adequate resection margin 4,5. Therefore, sublobar resection should be applied to the patients of early lung cancer when two cm of resection margin is achievable. The central location , obvious tumor infiltration in image study or presence of lymph node metastasis should be also avoided.

Patients and methods: The study will include surgical patients from six medical centers in Taiwan. All of the patients will receive complete study about the surgical risk and tumor staging before surgery. The patients will receive general anesthesia and pulmonary resection as the standard procedures including division of pulmonary vessels and bronchus. Either VATS (Video-assisted thoracoscopic surgery) or open surgery is acceptable for the surgical approaches. The patients will be randomly assigned to lobectomy and sublobar resection groups. Two cm of resection margin will be obtained in each patient in the sublobar resection group by wedge resection or segmentectomy. Standard lymph node dissection including the pulmonary hilum and mediastinum will be done in both groups of patients. For suspicious of pulmonary hilum or mediastinal lymph node metastasis, frozen pathological examination will be requested.

Post operative care and follow-up: The patients will be transferred to intensive care unit or surgical recovery room after surgery. Medication for pain control and postoperative rehabilitation education will be given to each patient after surgery. The chest tube will be removed after daily discharge less than 100 to 200 ml without air-leakage, adequate lung expansion noted in chest X ray imaging. The patient will be discharged from the hospital one or two days after removal of the chest tube. Whole body bone scan and CT scan will be given in every 6 months at least after surgery for postoperative follow-up.

Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer

post-operative pain assessment during hospital stay

The time interval from randomization to the earliest onset of any of the following events: tumor local recurrence, distant metastasis, and mortality

defined as any deviation from the normal postoperative course

the time interval from the day of surgery to discharge

the time interval from the day of surgery to the day of chest tube removal

the pulmonary function at 6, 12, and 24 months post-operation

National Taiwan University Hospital

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients receive sublobar resection, including wedge resection and segmentectomy.

Patients receive sublobar resection, which includes wedge resection and segmentectomy.

sublobar resection

Junjie Xi, MD

Di Ge, MD

The incidence rate of ground-glass opacity (GGO) has been increasing these years. A great number of retrospective studies suggested that sublobar resection was better for some GGO patients. However, no prospective clinical study supports the perspective. This study is prospective, multi-center, randomized-controlled. The aim of this study is to investigate whether sublobar resection is inferior to lobectomy for cT1N0M0 non-small-cell lung cancer or not.

Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

A Multi-center, Randomized-controlled, Open-label Clinical Trial: Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer

The data of all case report forms are to be collected and shared with other researchers at the end of followup.

survival status of patients after surgery

recurrence status of patients after surgery

recurrence rate of local and distant locations respectively

the rates of complications related to treatment during perioperative period

the rates of death related to treatment during perioperative period

Ruijin Hospital

RenJi Hospital

Fujian Medical University Union Hospital

The Second Affiliated Hospital of Dalian Medical University

First Affiliated Hospital of Wenzhou Medical University

Ningbo No.2 Hospital

Shanghai Zhongshan Hospital

Randomized by computer to receive a sublobar resection.

Randomized by computer to receive Stereotactic Body Radiotherapy (SBRT).

Patient decides with doctor to undergo a sublobar resection.

Patient decides with doctor to undergo SBRT.

Undergo surgery which removes a sublobar resection of the lung

Stereotactic Body Radiotherapy (SBRT)

Dennis Wigle, MD, PhD

This randomized phase II trial is for medically inoperable early stage non-small cell lung cancer (NSCLC) patients. It is designed to compare the number of patients who are disease free and alive at 2 years between Stereotactic Body Radiotherapy (SBRT) and surgical intervention arms. SBRT is less invasive and felt to be equally effective to surgery for early stage NSCLC. Surgery is currently the standard of care for these patients. The hypothesis of this study is that SBRT is at least as good as surgery for disease free survival at 2 years.

The current standard of care for Stage I Non-Small Lung Cancer (NSCLC) is sublobar surgical resection. Recent trials have suggested that early stage NSCLC might be successfully treated with SBRT amongst those who are medically inoperable. SBRT is the precise delivery of a high dose of radiation to control tumors while limiting damage to surrounding normal tissues. Patients on the SBRT arm will receive 54 Grays (Gy) in 3 fractions. One gray is the absorption of one joule of energy, in the form of ionizing radiation, per kilogram of matter. Recent advances with three-dimensional conformal and Intensity Modulated Radiotherapy (IMRT) techniques can now compensate for lung motion and allow delivery of high-dose, single fractions to the primary lung tumor for patients with clinical state I NSCLC.

Local control and survival results appear promising. SBRT for early stage lung cancer may offer a potentially equivalent, non-invasive treatment alternative to surgical resection. Additionally, SBRT may be associated with fewer complications and better quality of life. SBRT may be an acceptable or even preferred treatment option in higher-risk patients not able to tolerate a surgical lobectomy. This clinical dilemma is increasingly faced in our lung cancer practice at Mayo Clinic, with no comparative effectiveness data to guide treatment decisions.

Patients will be evaluated by both Thoracic Surgery and Radiation Oncology. Randomization can occur through either group but a patient must see both in consultation prior to randomization. For patients meeting enrollment criteria but unwilling to participate in randomization, observational arms for each of SBRT and sublobar resection will enroll up to 24 patients as part of the 96 patient total.

The patients will receive the following tests as part of their clinical care:

* Computed Tomography (CT)-Positron Emission Tomography (PET) will be used for mediastinal imaging
* Endobronchial/endoscopic ultrasound (EBUS/EUS)-Fine Needle Aspiration (FNA) or mediastinoscopy will be used for pathologic assessment of level 2 lymph nodes (N2) greater than 1 cm in the short axis on CT scan and/or SUV greater than 1.5 fold background
* Follow-up CT scans at 6 months, 12 months, 18 months, and 24 months for the Surgery and SBRT groups.
* Follow-up Pulmonary Function Tests at 1 year

Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients Non-Small Lung Cancer

Randomized Phase II Trial of Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients With Early Stage Non-Small Lung Cancer (NSCLC)

All patients who are alive and free of disease at 2 years. Disease burden will be determined by computed tomography.

Mayo Clinic

MD, PhD

Lobectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Segmentectomy will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Wide wedge resection will be chosen as the extent of pulmonary resection according to the institutional decision-making algorithm

Extent of pulmonary resection selected based on the institutional decision-making algorithm

Extent of pulmonary resection

Hong Kwan Kim, MD, PhD

The investigatros hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in participants with clinical stage IA non-small cell lung cancer.

The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm

The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.

1. Background

   * The standard extent of pulmonary resection for non-small cell lung cancer (NSCLC) is still lobectomy. However, recent advances in imaging technology and staging modalities and the widespread use of computed tomography (CT) screening have greatly increased the probability of detecting small-sized tumors, especially with ground-glass opacity (GGO) feature. Adenocarcinoma with GGO feature generally has a good prognosis due to its minimally invasive nature. Many studies have shown that these pathologically less invasive subtypes are associated with better prognoses compared with other subtypes such as acinar, papillary, micropapillary, and solid predominant invasive adenocarcinoma.
   * This recent change in the disease pattern of NSCLC from locally advanced and solid tumors to early and less invasive tumors with GGO features have led to a resurgence of interest in sublobar resection. Several retrospective studies have been conducted to compare the early and late outcomes including long-term survival between patients who underwent lobectomy and those who underwent sublobar resection.
   * Multiple reports have suggested that small-sized peripheral lung adenocarcinoma can be treated by sublobar resection, yielding survival rates similar to those of lobectomy. Lobectomy is considered to be too much for these less invasive tumors and sublobar resection would be sufficient for these tumors. If sublobar resection is equivalent to lobectomy in terms of their oncologic efficacy for the surgical treatment of NSCLC, the potential benefits of sublobar resection include (1) the preservation of vital lung parenchyma and pulmonary function, which may lead to improved early morbidities and mortalities and then late quality of life and (2) a chance for a second resection with a subsequent primary NSCLC.
   * However, when considering the published evidence for sublobar resection, its interpretation needs to be cautious. Since most studies were non-randomized, there may also have been selection bias in terms of preoperative patient risk factors (intentional vs. compromised sublobar resection), tumors of various histological subtypes or different tumor size in the study arms. Therefore, the results from two randomized trials of lobectomy versus sublobar resection for small-sized lung cancer currently ongoing in Japan (Japan Clinical Oncology Group \[0802\]) and in the United States (Cancer and Leukemia Group B \[140503\]) need to be awaited.
   * Based on these clinical circumstances and the published evidence, the investigators developed the decision-making algorithm regarding the surgical treatment for clinical stage IA NSCLC.
2. Hypothesis The investigators hypothesized that selection of surgical procedure according to the pre-defined institutional decision-making algorithm will not compromise the treatment outcomes including overall survival and disease-free survival in patients with clinical stage IA non-small cell lung cancer.
3. Purpose The purpose of this study is to determine the outcome of participants with clinical stage IA NSCLC treated by 3 types of surgical resection (wide wedge resection, segmentectomy, or lobectomy) according to the institutional decision-making algorithm
4. Study plan The investigators are planning to enroll 1,000 participants who meet the pre-defined eligibility criteria over 5 years.

Optimal Extent of Pulmonary Resection in Clinical Stage IA Non-Small Cell Lung Cancer

A Prospective Study to Optimize the Extent of Pulmonary Resection According to the Decision-Making Algorithm in Patients With Clinical Stage IA Non-Small Cell Lung Cancer

the time from the date of the operation until the first recurrence or the last follow-up.

the interval between the date of the operation and the date of death from any cause or the last follow-up

Loco-regional recurrence means tumor recurrence within the ipsilateral hemithorax and mediastinum

Systemic recurrence means tumor recurrence outside the bilateral hemithorax or mediastinum except for lung-to-lung metastasis

the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. This value reflects the pulmonary function of participants

the extent to which oxygen passes from the air sacs of the lungs into the blood. This value is also related to the pulmonary function of participants

C/T ratio is the consolidation/tumor ratio, which can be measured by the maximum diameter of consolidation to the maximum tumor diameter. Pathologic invasiveness of tumors can be predicted by this value.

(according to the 2015 WHO classification of lung tumors)

The investigators will check the incidence of lymph node metastasis from the permanent pathology report.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)	NCT06031181	Lung Adenocarci... Frozen Section Sublobar Resect...	Sublobar Resect...	18 Years - 80 Years	Fudan University
Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer	NCT03185754	Lung Cancer Surgery	Sublobar resect... lobectomy	30 Years - 80 Years	National Taiwan University Hospital
Comparison of Sublobar Resection and Lobectomy to Treat Lung Cancer	NCT03185754	Lung Cancer Surgery	Sublobar resect... lobectomy	30 Years - 80 Years	National Taiwan University Hospital
Sublobar Resection Versus Lobectomy for cT1N0M0 Non-small-cell Lung Cancer	NCT03108560	Carcinoma, Non-...	sublobar resect... lobectomy	18 Years - 75 Years	Shanghai Zhongshan Hospital
Sublobar Resection for Adenocarcinoma in Situ/Minimally Invasive Adenocarcinoma Diagnosed by Intraoperative Frozen Section (ECTOP-1019)	NCT06031181	Lung Adenocarci... Frozen Section Sublobar Resect...	Sublobar Resect...	18 Years - 80 Years	Fudan University
Stereotactic Body Radiotherapy (SBRT) Versus Sublobar Resection for High-Risk Patients Non-Small Lung Cancer	NCT01622621	Lung Neoplasms	Sublobar Resect... Stereotactic Bo...	18 Years -	Mayo Clinic
Optimal Extent of Pulmonary Resection in Clinical Stage IA Non-Small Cell Lung Cancer	NCT03066297	Stage IA Non-sm...	Extent of pulmo...	18 Years - 75 Years	Samsung Medical Center

Spots Global Cancer Trial Database for sublobar resection