Segmentectomy for ground glass-dominant invasive lung cancer with tumour diameter of 2-3 cm: protocol for a single-arm, multicentre, phase III trial (ECTOP1012).
Shiqi Chen, Qingyuan Huang, Fangqiu Fu...
https://pubmed.ncbi.nlm.nih.gov/38960464/Actively Recruiting
Led by Fudan University · Updated on 2024-06-03
307
Participants Needed
1
Research Sites
52 weeks
Total Duration
This trial focuses on patients with ground glass-dominant invasive lung cancer measuring 2 to 3 centimeters. It aims to confirm the therapeutic effects of segmentectomy, a surgical procedure, by evaluating the 5-year disease-free survival and post-operative lung function. The study is a Phase III, single-arm, multi-center trial led by Fudan University. Participants will undergo segmentectomy, which involves removing part of one lung lobe to fully remove the tumor while preserving more normal lung tissue. The surgery is performed specifically for those with ground glass-dominant lung nodules where the consolidation-to-tumor ratio is between 0 and 0.5, and tumor size is 2 to 3 cm. During the study, participants will be followed for outcomes such as 5-year disease-free survival, overall survival, lung function tests at six months and one year after surgery, tumor recurrence and metastasis sites, completion rates of segmentectomy and radical segmentectomy, and surgery-related complications. Follow-up assessments will occur for up to five years after surgery to monitor these outcomes.
CONDITIONS
Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
F
Fangqiu Fu, M.D.
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Fudan University
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants undergo segmentectomy surgery to remove part of the lung containing the tumor, followed by immediate post-operative care and monitoring of surgery-related complications until discharge or 30 days after surgery.
1 surgical procedure and approximately 1 to 2 post-operative visits
Duration - Up to 5 years
Participants are monitored for lung function, tumor recurrence, and overall survival with follow-up visits to assess recovery and long-term outcomes.
Visits at half year and one year for lung function tests, plus periodic assessments up to 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Shiqi Chen, Qingyuan Huang, Fangqiu Fu...
https://pubmed.ncbi.nlm.nih.gov/38960464/Fudan University
Lead Sponsor