Tomotherapy for Refractory Brain Metastases

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

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2018-09-01

Brief Summary

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This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.

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Detailed Description

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This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.

Conditions

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Brain Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental arm

Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases.

Intervention：tomotherapy

Group Type EXPERIMENTAL

tomotherapy

Intervention Type RADIATION

Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.

TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.

Interventions

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tomotherapy

Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions\<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.

TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2\*5d, q28d, up to 6cycles.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old;

Adequate end-organ function:

WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.

Exclusion Criteria

* • Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia).

* Unable or unwilling to comply with the study protocol.
* The expected survival time is less than 3 months.
* Patients who are anticipated in other clinical trials of brain metastases.
* Patients who has been treated with SRT in other hospitals
* Pregnant patients or female patients whose HCG is positive
* Unsuitable to participate in study, that in the opinion of the treating physician.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No