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NCT Number: NCT06289023

HA-WBRT-SIB for Brain Metastasis of Lung Cancer

Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.

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Key information

Conditions

Lung Neoplasm Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cognitive Function Hippocampal Avoidance Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Simultaneous Integrated Boost Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI);
  • 18-75 years old;
  • BM outside a 10 mm margin around either hippocampus;
  • at least one BM existed if prior resection of BM was done;
  • BM measuring less than 5.0 cm in maximal extent;
  • Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-2

Exclusion criteria

  • previous brain radiotherapy or brain metastasis resection;
  • history of malignancies other than lung cancer;
  • radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases
  • presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.

Treatment and study plan

HA-WBRT-SIB

Radiation

A total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV were boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week.

Primary outcomes

  1. OS

    Time frame: 24 months

    the time from the end of brain radiotherapy to death from any cause

Secondary outcomes

  1. PFS

    Time frame: 24 months

    the time from the end of brain radiotherapy to tumor progression or death from any cause

  2. iPFS

    Time frame: 24 months

    the time from the end of brain radiotherapy to intracranial tumor progression or death from any cause

  3. HVLT-R learning score

    Time frame: at baseline and 1, 3, and 6 months after radiotherapy

    The HVLT scores were calculated as the sum of trials 1, 2, and 3

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Hippocampal Avoidance Whole Brain Irradiation With Simultaneous Integrated Boost for the Treatment of Lung Cancer Brain Metastases：A Prospective Phase II Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 1, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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