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Trial Title:
Primary Tumor Resection for M1a Stage Lung Cancer
NCT ID:
NCT06547710
Condition:
Lung Cancer Metastatic
Surgical Resection
Conditions: Official terms:
Lung Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP),
numbered as ECTOP-1023. This study aims to explore the safety and efficacy of primary
lesion resection in the treatment of M1a stage lung cancer with pleural dissemination
found during surgery, and to more accurately evaluate whether primary lesion resection
can improve the OS and quality of life of the corresponding patients.
Criteria for eligibility:
Study pop:
This clinical trial is a single-arm, multicenter, prospective, confirmatory phase II
clinical study, which mainly evaluates the efficacy and safety of primary lesion
resection for patients with M1a stage lung cancer who have occult pleural dissemination
during surgery (Figure 1). Since it is unethical not to perform primary lesion resection
during surgery for such patients, this study is a single-arm one. Primary lesion
resection should be a resection that can completely remove the primary lesion, including
lobectomy and sublobar resection.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
1. Volunteer to participate in clinical research, willing to follow and able to
complete all trial procedures;
2. Aged 18-80 years (including critical values) when signing the informed consent form;
3. ECOG score 0 or 1;
4. No previous lung cancer surgery;
5. Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
6. Occult pleural metastasis found during surgery;
7. Preoperative lymph node staging is cN0;
8. First-time treatment and no radiotherapy or chemotherapy.
Exclusion Criteria:
1. The lesion cannot be completely removed surgically;
2. Cytological or histological pathology confirms other lung malignancies other than
lung cancer;
3. Patients who have undergone lung cancer surgery before;
4. Patients who have received radiotherapy or chemotherapy and are not treatment-naive
patients.
Gender:
All
Gender based:
Yes
Gender description:
18-75
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen Haiquan, MD
Phone:
+86-21 64175590
Phone ext:
1707
Email:
hqchen1@yahoo.com
Start date:
April 1, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06547710
