A Prospective, Single-Arm Phase II Clinical Trial of Standard Systemic Therapy Combined With Spatial Fractionated Radiotherapy (SFRT) for Oligoprogressive Non-small Cell Lung Cancer (NSCLC)

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to learn if spatially fractionated radiotherapy (SFRT) combined with standard systemic therapy can treat oligoprogressive non-small cell lung cancer (NSCLC) in patients who have progressed after at least one line of systemic therapy. The main question it aims to answer is: \- Can the combination of SFRT and standard systemic therapy improve progression-free survival (PFS) compared to standard systemic therapy alone? Participants will: * Undergo SFRT treatment for oligoprogressive lesions, with specific dose fractionation determined by the radiation oncologist based on clinical parameters. * Continue their standard systemic therapy, which may include chemotherapy, targeted therapy, or immunotherapy, as adjusted by their treating physician. * Have regular follow-up assessments, including imaging studies to evaluate treatment response and monitor for disease progression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older, regardless of sex.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, with an expected survival of more than 3 months.

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with oligometastatic disease (up to 5 separate progressive lesions), having received and progressed after at least one line of systemic therapy (chemotherapy, targeted therapy, or immunotherapy).

• The target lesion for radiotherapy has not been previously irradiated, or it has been more than 6 months since the last radiotherapy.

• The diameter of the target lesion is at least 4.5 cm, suitable for lattice radiotherapy planning.

• No new or enlarged brain metastases; if brain metastases were previously treated with standard radiotherapy, they must be stable.

• Adequate hematologic and biochemical profiles, including hemoglobin ≥9.0 g/dL, absolute neutrophil count (ANC) ≥1500/mm³, platelet count ≥100,000/mm³, total bilirubin ≤1.5 times the upper limit of normal (ULN) (or direct bilirubin ≤ULN if total bilirubin \>1.5 times ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (or ≤5 times ULN if liver involvement is present), and creatinine ≤1.5 times ULN (or glomerular filtration rate \[GFR\] \>60 mL/min if creatinine \>1.5 times ULN).

• For women of childbearing potential, a negative pregnancy test within 7 days prior to registration.

Locations
Other Locations
China
2nd Affiliated Hospital, School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Ting Zhang, phD.
zezht@zju.edu.cn
+8657187783521
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 25
Treatments
Experimental: SFRT plus systemic therapy
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov