Safety and Feasibility of Surgery After Conversion Therapy for Locally Advanced and Advanced NSCLC

NCT04945928 | Active Not Recruiting

• 1 other identifier: RTS-013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is one of the most common malignant tumors worldwide and the mortality ranks first in the world. In recent years, with the development of targeted therapy and immunotherapy, the overall survival of lung cancer patients has improved significantly. However, the inoperable advanced tumor remains the main reason for the poor prognosis of lung cancer. Thus, we aim to carry out this single-arm, prospective study to evaluate the safety and feasibility of surgery after conversion therapy for locally advanced and advanced non-small cell lung cancer.

Conditions

Pulmonary Neoplasm; Advanced Cancer; Locally Advanced Cancer

Keywords

Conversion Therapy; Lung Cancer; Locally Advanced and Advanced NSCLC

Outcome Measures

Primary Outcomes (1)

• perioperative morbidity

  rate of perioperative complications, mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula

  postoperative in-hospital stay up to 30 days

Secondary Outcomes (11)

• lymph nodes counts

  At operation day

• R0 rate

  postoperative in-hospital stay up to 30 days

• operation time

  At operation day

• blood loss

  At operation day

• operative complications

  At operation day

Study Arms (1)

Surgery after conversion therapy

EXPERIMENTAL

Participants with locally advanced or advanced NSCLC who received first-line treatment have been evaluated as resectable after multidisciplinary discussion involving the department of thoracic surgery, respiratory medicine, radiology and oncology.

Procedure: Surgery

Interventions

Surgery PROCEDURE

Participants having been evaluated as operable after receiving first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) will receive surgery.

Surgery after conversion therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent;
• More than 18 years old with no limit of sex;
• Pathologically confirmed stage T4N0-3 or T1-3N2-3 NSCLC with residual tumor after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) evaluated operable for radical resection; pathologically confirmed stage IVA NSCLC evaluated operable after first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.);
• ASA score: I-III;
• Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

You may not qualify if:

• Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation;
• Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
• Unable to receive radical resection;
• Need of palliative or emergency operation due to lung abscess or hemoptysis;
• Having received neoadjuvant chemoradiotherapy.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• He-Cheng Li, doctor

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: June 30, 2021
• Study Start: August 27, 2021
• Primary Completion: June 5, 2024
• Study Completion (Estimated): June 5, 2026
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

CN (1)