NCT05717803 Segmentectomy for Ground Glass-dominant Invasive Lung Cancer (ECTOP-1012)
| NCT ID | NCT05717803 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Segmentectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 307 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 307 participants in total. It began in 2023-02-15 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1012. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for ground glass-dominant invasive lung cancer with size of 2-3cm. The main questions it aims to answer are: * The 5-year disease-free survival of patients having ground glass-dominant invasive lung cancer with size of 2-3cm; * The post-operative lung function tests after receiving segmentectomy. Participants will receive segmentectomy as the surgical procedure.
Eligibility Criteria
Inclusion Criteria: * Patients who sign the informed consent form and are willing to complete the study according to the plan; * Aged from 18 to 80 years old; * ECOG equals 0 or 1; * Not receiving lung cancer surgery before; * Confirmed to be invasive lung adenocarcinoma intraoperatively or postoperatively; * Ground glass-dominant lung nodules * Consolidation-to-tumor ratio (CTR) ranges from 0 to 0.5, and tumor size ranges from 2 to 3cm; * cN0 without distant metastasis; * Tumors could be completely resected assed by surgeons; * Not receiving chemotherapy or radiotherapy before. Exclusion Criteria: * CTR is not 0-0.5, or size is not 2-3cm; * Tumors could not be completely resected assed by surgeons; * Not lung adenocarcinoma diagnosed cytologically or pathologically; * Receiving lung cancer surgery before; * Receiving radiotherapy or chemotherapy.
Contact & Investigator
Haiquan Chen, M.D.
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05717803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Segmentectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05717803 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 307 participants.
Is NCT05717803 currently recruiting?
Yes, NCT05717803 is actively recruiting participants. Contact the research team at fufangqiu12@163.com for enrollment information.
Where is the NCT05717803 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05717803 clinical trial?
NCT05717803 is sponsored by Fudan University. The principal investigator is Haiquan Chen, M.D. at Fudan University. The trial plans to enroll 307 participants.