Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Официальное название

A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus (VS) Standard-Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage 2A/B Non-Small Cell Lung Cancer

Обзор

The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial

Вмешательства

• Лучевая терапия Hypo-Fractionation
  62.5 Gy in 25 fractions of 2.5 Gy/fraction
• Лучевая терапия Standard-Fractionation
  60 Gy in 30 fractions of 2 Gy/fraction

Первичные конечные точки

• Locoregional control (LRC) [Срок оценки: From enrollment for up to 7.5 years]

Вторичные конечные точки (6)

• Acute toxicities [Срок оценки: From enrollment for up to 7.5 years]
• Late toxicities [Срок оценки: From enrollment for up to 7.5 years]
• Progression free survival (PFS) [Срок оценки: From enrollment for up to 7.5 years]
• Overall survival (OS) [Срок оценки: From enrollment for up to 7.5 years]
• Measuring the Impact of Treatment on the Quality of life (QOL) [Срок оценки: From enrollment for up to 7.5 years]
• Measuring the Impact of Treatment on the Quality of life (QOL) [Срок оценки: From enrollment for up to 7.5 years]

Критерии участия

Критерии включения

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males and females age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
• Measurable disease by RECIST 1.1
• Women of childbearing potential must have a negative serum pregnancy test within one month prior to initiating treatment
• Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
• No Positron Emission Tomography (PET)/CT evidence of metastatic disease
• An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons
• If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy
• Adequate organ function per laboratory results

Критерии исключения

• Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator
• Is pregnant or breastfeeding
• Active connective tissue disorders, such as active lupus or scleroderma
• Known Acquired Immune Deficiency (HIV (+)/AIDS)
• Has a known allergic reaction to any excipient contained in the study drug formulations
• Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
• Prior thoracic radiotherapy

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

Лечение

Центры проведения

США · 6 центров

• The University of Kansas Cancer Center, Westwood Campus — Kansas City
• The University of Kansas Cancer Center, Overland Park Clinic — Overland Park
• KUCC MCA- TUKHS, Saint Francis Hospital — Topeka
• The University of Kansas Cancer Center, North Clinic — Kansas City
• The University of Kansas Cancer Center, Lee's Summit Clinic — Lee's Summit
• University of Kansas Cancer Center, North Kansas City Hospital — North Kansas City

Идентификаторы

NCT: NCT04992780 · IIT-2021-LU-HypoIMRT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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