NCT06037733

Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy

Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Hubei Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy

Detailed description

Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.

Conditions

• Advanced Non-Small Cell Squamous Lung Cancer
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
RADIATION	CTV omitted or delineated	Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.

Timeline

• Start date: 2024-03-13
• Primary completion: 2026-03-13
• Completion: 2027-10-08
• First posted: 2023-09-14
• Last updated: 2024-03-15

Locations

1 site across 1 country: China