Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06028412
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-08
First Post:
2023-08-29
Brief Title:
Comparison of Sublobar and Lobectomy in Small 2 Cm or Less 05CTR1 Non-small Cell Lung Cancer a Prospective Multicenter Randomized Controlled Study
Sponsor:
Xiaolong Yan Dr
Organization:
Tang-Du Hospital
Study Overview
Official Title:
Comparison of Segmentectomy and Lobectomy in Small 2 Cm or Less 05CTR1 Non-small Cell Lung Cancer a Prospective Multicenter Randomized Controlled Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The early NSCLCNon-small cell lung cancer patients with partial solid nodules mainly composed of solid components whose maximum tumor diameter was 20cm and 05CTRConsolidation tumor ratio1 as indicated by preoperative thin slice CT were selected as the study objects The short-term and long-term effects of segmental resection and lobectomy under Thoracoscopy were compared to provide high-level evidence for the selection of surgical treatment methods for early NSCLC
Detailed Description:
Since Cahan reported on radical lobectomy in 1960 lobectomy has become the standard surgical method for lung cancer and its efficacy has long been verified in clinical practice In 2006 the National Comprehensive Cancer Network NCCN lung cancer diagnosis and treatment guidelines listed thoracoscopic lobectomy as one of the standard surgical methods for early non-small cell lung cancer NSCLC for the first time However in recent years an increasing number of retrospective studies have found that the efficacy of subpulmonary lobectomy in treating stage IA NSCLC is similar to that of lobectomy Not only is there no difference in survival rate but perioperative complications and mortality are lower and lung function is also more protected Anatomical segmental lung resection was also recommended as one of the surgical options for early NSCLC patients by the US NCCN guidelines in 2010 With the development of thin-layer CT diagnosis and treatment technology the detection rate of early lung cancer with main imaging manifestations such as small pulmonary nodules and ground glass nodules GGO has improved The solid components in GGO are often considered as infiltrating components with a high possibility The Lung Cancer Surgery Research Group LCSSG of the Japanese Clinical Oncology Group used Solid Component Ratio for ground glass nodules which stratified the study population by the ratio of the maximum solid component diameter to the maximum tumor diameter and began multiple clinical trials related to subpulmonary lobectomy And these clinical trials will clarify whether subpulmonary lobectomy can be used as a standard surgical procedure for early NSCLC patients
Among them the recently released research results of the JCOG 0802 trial suggest that for peripheral NSCLC with tumor diameter 2cm and CTR05 the segmental resection group even outperforms the lobectomy group in terms of 5-year OS as the main endpoint which overturns peoples understanding of early lung cancer surgery methods The JCOG 0802 results showed that the local recurrence rate in the segmental resection group was 105 while in the lobectomy group it was 54 p00018 However the relatively high value of local recurrence in the segmental resection group did not result in a decrease in the final 5-year RFS and 5-year OS And in the JCOG 0201 study the tumor size of all recurrent cases within 5 and 10 years after surgery was 1cm and the majority were patients with CTR10 However it is worth noting that the JCOG 0802 experiment also has corresponding problems 1 The initial enrollment condition is CTR025 and with the release of the long-term results of the JCOG 0201 experiment the CTR value is adjusted from 025 to 05 2 More than half of the enrolled patients have pure solid nodules CTR10 3 During the research phase preoperative 3D reconstruction technology was not used for surgical resection range planning Therefore the experimental results of JCOG 0802 deserve further in-depth research and the choice of surgical methods for patients with partial solid nodules PSN with a diameter 2cm and a CTR1 is also the most perplexing issue for thoracic surgeons at present Someone has proposed that for PSN patients with a diameter 2cm subpulmonary lobectomy surgery can replace traditional lobectomy surgery and patients have similar prognosis However this theory is derived from retrospective studies and there is a lack of relevant prospective randomized controlled study data which should be confirmed in prospective studies Therefore the issues raised in the above research pose key scientific questions for the implementation of this project whether segmental resection of the lung has similar long-term survival and short-term efficacy to lobectomy for patients with partial solid nodules with a tumor diameter of 2cm and 05CTR1 requires a multicenter prospective non-inferiority randomized controlled study to answer
In summary based on previous literature and clinical studies this project conducted a multicenter prospective open non-inferiority randomized controlled study in conjunction with multiple well-known hospitals in China targeting early NSCLC patients with partial solid nodules different from JCOG 0802 excluding solid nodules with CTR1 with a maximum tumor diameter of 20cm and a maximum tumor diameter of 05CTR1 on preoperative thin-layer CT The main endpoint of the study was 5-year DFS Compare the short-term and long-term efficacy of VATS pulmonary segment resection and lobectomy in the treatment of early NSCLC The expected results of this project will further fill the gaps in previous clinical research and provide high-level evidence for the selection of surgical treatment methods for early NSCLC It is expected to enrich or rewrite the current surgical treatment guidelines for lung cancer improve the level of NSCLC surgical treatment and have important theoretical significance and practical value
Among them the recently released research results of the JCOG 0802 trial suggest that for peripheral NSCLC with tumor diameter 2cm and CTR05 the segmental resection group even outperforms the lobectomy group in terms of 5-year OS as the main endpoint which overturns peoples understanding of early lung cancer surgery methods The JCOG 0802 results showed that the local recurrence rate in the segmental resection group was 105 while in the lobectomy group it was 54 p00018 However the relatively high value of local recurrence in the segmental resection group did not result in a decrease in the final 5-year RFS and 5-year OS And in the JCOG 0201 study the tumor size of all recurrent cases within 5 and 10 years after surgery was 1cm and the majority were patients with CTR10 However it is worth noting that the JCOG 0802 experiment also has corresponding problems 1 The initial enrollment condition is CTR025 and with the release of the long-term results of the JCOG 0201 experiment the CTR value is adjusted from 025 to 05 2 More than half of the enrolled patients have pure solid nodules CTR10 3 During the research phase preoperative 3D reconstruction technology was not used for surgical resection range planning Therefore the experimental results of JCOG 0802 deserve further in-depth research and the choice of surgical methods for patients with partial solid nodules PSN with a diameter 2cm and a CTR1 is also the most perplexing issue for thoracic surgeons at present Someone has proposed that for PSN patients with a diameter 2cm subpulmonary lobectomy surgery can replace traditional lobectomy surgery and patients have similar prognosis However this theory is derived from retrospective studies and there is a lack of relevant prospective randomized controlled study data which should be confirmed in prospective studies Therefore the issues raised in the above research pose key scientific questions for the implementation of this project whether segmental resection of the lung has similar long-term survival and short-term efficacy to lobectomy for patients with partial solid nodules with a tumor diameter of 2cm and 05CTR1 requires a multicenter prospective non-inferiority randomized controlled study to answer
In summary based on previous literature and clinical studies this project conducted a multicenter prospective open non-inferiority randomized controlled study in conjunction with multiple well-known hospitals in China targeting early NSCLC patients with partial solid nodules different from JCOG 0802 excluding solid nodules with CTR1 with a maximum tumor diameter of 20cm and a maximum tumor diameter of 05CTR1 on preoperative thin-layer CT The main endpoint of the study was 5-year DFS Compare the short-term and long-term efficacy of VATS pulmonary segment resection and lobectomy in the treatment of early NSCLC The expected results of this project will further fill the gaps in previous clinical research and provide high-level evidence for the selection of surgical treatment methods for early NSCLC It is expected to enrich or rewrite the current surgical treatment guidelines for lung cancer improve the level of NSCLC surgical treatment and have important theoretical significance and practical value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None