Tomotherapy for Refractory Brain Metastases (TRBM)
This study is currently recruiting participants.
Verified January 2017 by Jianping Xiao, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jianping Xiao, Chinese Academy of Medical Sciences
First received: January 19, 2017
Last updated: NA
Last verified: January 2017
History: No changes posted
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
Primary Outcome Measures:
Secondary Outcome Measures:
- Overall survival rate [ Time Frame: up to 3 years ]
- progress free survival rate [ Time Frame: up to 1 year ]
- local control rate [ Time Frame: up to 1 year ]
- intracranial progress free survival rate [ Time Frame: up to 1 year ]
- adverse event [ Time Frame: from the day of radiation, up to 6 months ]
- cause of death [ Time Frame: from the day of radiation to death date, up to 5 years ]
| Estimated Enrollment:
| Actual Study Start Date:
||September 1, 2014
| Estimated Study Completion Date:
||September 1, 2018
| Estimated Primary Completion Date:
||September 1, 2018 (Final data collection date for primary outcome measure)
Experimental: 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.
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.
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.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT03027544
|Chinese Academy of Medical Sciences
|Beijing, Beijing, China, 100021 |
|Contact: Jianping Xiao 86-13811026919 email@example.com |
Chinese Academy of Medical Sciences
||Chinese Academy of Medical Sciences
||Jianping Xiao, Dr, Chinese Academy of Medical Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 19, 2017
||January 19, 2017
|Individual Participant Data (IPD) Sharing Statement:
|Plan to Share IPD:
||the baseline characteristics and treatment plan can be shared with other researchers when the research paper has been published. The IPD will be sent by email if applied.
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
Keywords provided by Jianping Xiao, Chinese Academy of Medical Sciences:
multiple brain metastases
large brain metastases
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2017
Neoplasms, Second Primary
Central Nervous System Neoplasms
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Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases