HA-WBRT-SIB for Brain Metastasis of Lung Cancer

NCT06289023 | Completed Phase 2

• 1 other identifier: NCC1278
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Neoplasm; Brain Metastases; Simultaneous Integrated Boost; Hippocampal Avoidance; Cognitive Function

Keywords

Lung Neoplasm; Brain Metastases; Simultaneous integrated boost; Hippocampal avoidance; Cognitive function

Outcome Measures

Primary Outcomes (1)

• OS

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

  24 months

Secondary Outcomes (3)

• PFS

  24 months

• iPFS

  24 months

• HVLT-R learning score

  at baseline and 1, 3, and 6 months after radiotherapy

Study Arms (1)

HA-WBRT-SIB

EXPERIMENTAL

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.

Radiation: HA-WBRT-SIB

Interventions

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.

HA-WBRT-SIB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (MRI);
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Li Z, Wang J, Deng L, Zhai Y, Zhang T, Bi N, Wang J, Wang X, Liu W, Xiao Z, Chen D, Lv J, Feng Q, Wang W, Zhou Z. Hippocampal avoidance whole-brain radiotherapy with simultaneous integrated boost in lung cancer brain metastases and utility of the Hopkins verbal learning test for testing cognitive impairment in Chinese patients: a prospective phase II study. BMC Cancer. 2024 Jul 26;24(1):899. doi: 10.1186/s12885-024-12559-1.

  PMID: 39060968 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: December 31, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)