HA-WBRT-SIB for Brain Metastasis of Lung Cancer

Phase 2

Completed

• Conditions: Simultaneous Integrated Boost; Lung Neoplasm; Brain Metastases; Hippocampal Avoidance; Cognitive Function
• Interventions: Radiation: HA-WBRT-SIB

• Registration Number: NCT06289023
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-02-24
• Last Update Submitted: 2024-02-24
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HA-WBRT-SIB	HA-WBRT-SIB	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.

Primary Outcome Measures

Name	Time	Method
OS	24 months	the time from the end of brain radiotherapy to death from any cause

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	the time from the end of brain radiotherapy to tumor progression or death from any cause
HVLT-R learning score	at baseline and 1, 3, and 6 months after radiotherapy	The HVLT scores were calculated as the sum of trials 1, 2, and 3
iPFS	24 months	the time from the end of brain radiotherapy to intracranial tumor progression or death from any cause

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China