HA-WBRT-SIB for Brain Metastasis of Lung Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function; Brain Metastases; Lung Neoplasm; Simultaneous Integrated Boost; Hippocampal Avoidance
• Intervention / Treatment: Radiation: HA-WBRT-SIB

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Radiation: HA-WBRT-SIB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	the time from the end of brain radiotherapy to death from any cause	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: February 24, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Cognitive function; Brain Metastases; Lung Neoplasm; Simultaneous integrated boost; Hippocampal avoidance
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: NCC1278

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No