HFSRT With Concurrent TMZ for Large BMs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2022-12-03

Brief Summary

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A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.

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Detailed Description

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A previous single arm phase II trial and propensity- matched study of our institution have shown that HFSRT combined with concurrent TMZ was safe and efficient for patients with BMs of ≥ 6cc in volume. The 1-year local control, intracranial progression free survival, progression free survival and overall survival rates were better than HFSRT alone group. Thus, the investigator conducted this randomized phase III trial to broad the sample size and verify our previous results. To finish the study in time, the investigator designed a multi-center trial.

Conditions

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Brain Metastases Chemotherapy Radiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.

Group Type ACTIVE_COMPARATOR

hypofractionated radiotherapy

Intervention Type RADIATION

the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

CRT group

patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.

Group Type EXPERIMENTAL

Temozolomide

Intervention Type DRUG

75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.

hypofractionated radiotherapy

Intervention Type RADIATION

the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Interventions

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Temozolomide

75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.

Intervention Type DRUG

hypofractionated radiotherapy

the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT;
* the number of BMs ≤ 3
* the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm;
* Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs;
* Age: 18-75 years old;
* Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results\<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range.

Exclusion Criteria

* patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia);
* unable or unwilling to comply with the study protocol;
* patient whose survival expectancy was less than 3 months;
* the large BM locates in brainstem;
* patient who anticipated in other clinical trials of brain metastases;
* the large lesions have been treated with SRT in other hospitals;
* pregnant patients or female patients whose HCG is positive.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No