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Stereotactic Radiotherapy Plus Temozolomide for Refractory Brain Metastases

NCT02654106 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2017-06-06

No results posted yet for this study

Summary

This clinical trial was designed to investigate the efficiency and toxicity of fractionated stereotactic radiotherapy(FSRT) combined with Temozolomide(TMZ) for refractory brain metastases.

Conditions

Interventions

RADIATION

Fractionated Stereotactic Radiotherapy

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.

DRUG

Temozolomide

concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2\*5d, q28d, 6cycles

Sponsors & Collaborators

  • Cancer Foundation, China

    collaborator OTHER

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jianping Xiao · Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654106 on ClinicalTrials.gov