Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHubei Cancer Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);
After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
Age 18 to 80 years old, performance status 0-1;
measurable or evaluable lesions;
Disqualifiers
tumor progress after therapy with immunotherapy and chemotherapy
EGFR, ALK, or ROS1 mutation;
Previous thoracic radiotherapy;
grade 2 or more immune-related adverse events after induction immunotherapy
Trial design
Design model
Parallel
Treatments tested in this trial
CTV omitted or delineated
RadiationPatients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: CTV-omittedExperimental treatment 1 intervention
Group B: CTV-delineatedActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
grade 2 or more pneumonitis
Time frame
up to 6 monthsSecondary outcomes
1
local/regional control rate
Time frame
up to 12 months2
Progress free survival
Time frame
up to 12 months3
grade 3 or more pneumonitis
Time frame
up to 6 months4
grade 3 or more esophagitis
Time frame
up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov