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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Лучевая терапия 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.

Первичные конечные точки

• grade 2 or more pneumonitis [Срок оценки: up to 6 months]

Вторичные конечные точки (4)

• local/regional control rate [Срок оценки: up to 12 months]
• Progress free survival [Срок оценки: up to 12 months]
• grade 3 or more pneumonitis [Срок оценки: up to 6 months]
• grade 3 or more esophagitis [Срок оценки: up to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Hubei Cancer Hospital — Ухань

Идентификаторы

NCT: NCT06037733 · OMCTV-HC-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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