HA-WBRT-SIB for Brain Metastasis of Lung Cancer

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06289023
• Other study ID #: NCC1278
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Cognitive Function
• Lung Neoplasm
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

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, ?ve times a week.

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	the time from the end of brain radiotherapy to death from any cause	24 months
Secondary	PFS	the time from the end of brain radiotherapy to tumor progression or death from any cause	24 months
Secondary	iPFS	the time from the end of brain radiotherapy to intracranial tumor progression or death from any cause	24 months
Secondary	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