Segmentectomy for Solid-dominant Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Segmentectomy.
- Who it may be relevant to
- Registry conditions: Segmentectomy, Lung Adenocarcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Segmentectomy for Solid-dominant GGO-featured Invasive Lung Cancer With Size of 2-3cm: a Single-arm, Multi-center, Phase III Trial
Overview
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1025. The goal of this clinical trial is to confirm the theraputic effect of segmentectomy for solid-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 solid-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.
Interventions
- Procedure Segmentectomy
The lungs are divided into multiple lobes. A segmentectomy involves the removal of part of one of the lobes of the lung to entirely remove a cancerous tumor. segmentectomy can preserve more normal functional lung tissues.
Primary outcome measures
- 5-year disease-free survival [Time frame: 5 years]
Secondary outcome measures (6)
- Lung function test [Time frame: Half year and one year after surgical resection]
- 5-year overall survival [Time frame: 5 years]
- The site of tumor recurrence and metastasis [Time frame: From date of surgery to the last follow-up or date of death from any cause, whichever came first, assessed up to 5 years.]
- Segmentectomy completion rate [Time frame: From the beginning of the surgery to the end of the surgery.]
- Radical segmentectomy (R0 resection) completion rate [Time frame: From surgery to the release of the final pathology report, an average of two weeks.]
- Surgery-related complications [Time frame: From surgery to patient discharge or 30 days after surgery.]
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 0.5 to 1, 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 0.5-1, 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06634966 · ECTOP-1025