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Recruiting NCT06037733

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

No phase Interventional Advanced Non-Small Cell Squamous Lung Cancer Radiotherapy Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CTV omitted or delineated.
Who it may be relevant to
Registry conditions: Advanced Non-Small Cell Squamous Lung Cancer, Radiotherapy, Immunotherapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • grade 2 or more pneumonitis [Time frame: up to 6 months]
Secondary outcome measures (4)
  • local/regional control rate [Time frame: up to 12 months]
  • Progress free survival [Time frame: up to 12 months]
  • grade 3 or more pneumonitis [Time frame: up to 6 months]
  • grade 3 or more esophagitis [Time frame: up to 6 months]

Eligibility criteria

Inclusion criteria

  • 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;
  • Survival expectancy is not less than 6 months;
  • adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion criteria

  • 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
  • Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
  • Pregnant or lactating women
  • undergoing other clinical trials;
  • Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
  • Patients with HIV positive and undergoing antiviral therapy;
  • Active tuberculosis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Hubei Cancer Hospital — Wuhan

Identifiers

NCT: NCT06037733 · OMCTV-HC-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗