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

October 18, 2022 updated by: First People's Hospital of Hangzhou

Dose-escalation by Hypofractionated Stereotactic Radiotherapy Simultaneous Integrated Boost IMRT for Brain Metastases in Non Small Cell Lung Cancer：A Phase I Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

21

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China, 310000
        • Recruiting
        • Kaicheng Pan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histology confirmed that it was non-small cell lung cancer
  • 1 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
  • 2cm<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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Stereotactic Radiotherapy for Brain Metastases
Radiation: Hypofractionated Stereotactic Radiotherap
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD
Time Frame: 1 years
maximum tolerated dose
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ARE
Time Frame: 2 years
adverse radiation effect
2 years
iPFS
Time Frame: 2 years
intracranial progression-free survival defines as intervals from treatment to intracranial disease progression or death
2 years
OS
Time Frame: 2 years
overall survival (OS) intervals from treatment to death or last follow-up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Collaborators

Hangzhou Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeHSRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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