Primary Tumor Resection for M1a Stage Lung Cancer

NCT06547710 | Recruiting

• 1 other identifier: ECTOP-1023
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer Metastatic; Surgical Resection

Outcome Measures

Primary Outcomes (1)

• Median overall survival

  Median overall survival for M1a patients underging surgery.

  About 10months.

Secondary Outcomes (3)

• 2-year overall survival

  2 years

• 5-year overall survival

  5 years

• FEV1 and FVC

  0.5 year

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 18-75
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Volunteer to participate in clinical research, willing to follow and able to complete all trial procedures;
• Aged 18-80 years (including critical values) when signing the informed consent form;
• ECOG score 0 or 1;
• No previous lung cancer surgery;
• Intraoperative or postoperative pathological confirmation of M1a stage lung cancer;
• Occult pleural metastasis found during surgery;
• Preoperative lymph node staging is cN0;
• First-time treatment and no radiotherapy or chemotherapy.

You may not qualify if:

• The lesion cannot be completely removed surgically;
• Cytological or histological pathology confirms other lung malignancies other than lung cancer;
• Patients who have undergone lung cancer surgery before;
• Patients who have received radiotherapy or chemotherapy and are not treatment-naive patients.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Fangqiu Fu, MD

CONTACT

021-64175590; fufangqiu12@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Thoracic Surgery Department

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)