Dose-escalation by Hypofractionated Stereotactic Radiotherapy for Brain Metastases in Non Small Cell Lung Cancer

NCT05588206 | Unknown Phase 1

• 1 other identifier: DeHSRT
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to assess the safety and feasibility of delivering SBRT to patients with limited BMs (less than 10 lesions of lung cancer) by establishing the maximally tolerated dose (MTD) of SABR in 5 fractions.

Conditions

Non Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Brain Metastases

Keywords

lung cancer; Brain Metastases; Hypofractionated Stereotactic Radiotherapy

Outcome Measures

Primary Outcomes (1)

• MTD

  maximum tolerated dose

  1 years

Secondary Outcomes (3)

• ARE

  2 years

• iPFS

  2 years

• OS

  2 years

Study Arms (1)

Hypofractionated Stereotactic Radiotherapy for Brain Metastases

EXPERIMENTAL

Radiation: Hypofractionated Stereotactic Radiotherap

Interventions

Hypofractionated Stereotactic Radiotherap RADIATION

A standard 3+3 statistical design was employed. Three patients will initially be treated at dose level 1, 6 Gy in 5 fractions, 3 fractions a week. Dose limiting toxicities (DLT) were defined as any grade 3-5 radiation injury or any non-hematologic toxicity felt to be possibly, probably, or definitely related to radiation, identified within the evaluation period of 3 months following the completion of radiotherapy.

Hypofractionated Stereotactic Radiotherapy for Brain Metastases

Eligibility Criteria

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

You may qualify if:

• Histology confirmed that it was non-small cell lung cancer
• to 10 brain metastases detected by magnetic resonance imaging (MRI)
• A life expectancy of \>3 months according to the DS GPA.
• KPS ≥70
• Control of the primary lesions (thorax) at the time of SBRT
• cm\<Tumor size ≤ 4 cm
• Age of 18-75 years old
• Patients must be able to undergo contrast enhanced MRI for planning
• Adequate bone marrow and organ function

You may not qualify if:

• other malignant tumors
• Prior surgery to brain metastasis
• Prior brain radiotherapy
• Non-small cell lung cancer with more than 10 brain metastases detected by MRI
• Contraindication to receiving radiotherapy.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Hangzhou Cancer Hospital: collaborator

Study Sites (1)

Kaicheng Pan

Hangzhou, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; 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

Central Study Contacts

Bing Xia

CONTACT

057156006382; bingxia_hzch@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

CN (1)