Omitting CTV for Locally Advanced NSCLC Responded to Immunotherapy and Chemotherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHubei Cancer Hospital
About this trial
Radical radiotherapy is critical for locally advanced non small cell lung cancer(NSCLC ). Our previous sturdy indicated that patients who received induction immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis.Grade 2 or more pneumonitis patients 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 CTV radiation is feasible for patients undergoing concurrent radio-chemotherapy for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to induction 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed non-small cell lung cancer;
stage IIIA or IIIB or IIIC according to the 8th edition of the TNM cancer staging system of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control（UICC);
inoperable or refuses surgery after induction therapy with immunotherapy and chemoradiotherapy;
After ≥2 cycles of induction chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
Disqualifiers
tumor progress after induction with immunothearoy 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 induction therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radical 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