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Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer

NCT06523673 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-08-30

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:

Does SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?

Researchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.

Participants will:

Take SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.

Conditions

  • Metastatic Non-Small Cell Lung Cancer
  • NSCLC Stage IV
  • OligoProgressive Metastatic Disease

Interventions

RADIATION

Stereotactic Body Radiotherapy

The dose of radiation therapy is determined by the radiologist based on the clinical parameters of the lesion, including tumor size and location. In most cases, radiotherapy fractionation regimens range from 27-30 Gy/3 Fractions or 30-50 Gy/5 Fractions, and appropriate radiotherapy doses covering 27-70 Gy/3-10 Fractions can also be selected by the radiologist based on radiation limitations of neighboring endangered organs.

DRUG

second-line systemic therapy

a second-line docetaxel/albumin-bound paclitaxel-based systemic therapy regimen

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Fuming Qiu, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523673 on ClinicalTrials.gov