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HFSRT With Concurrent TMZ for Large BMs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778541
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jianping Xiao, Chinese Academy of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Metastases Chemotherapy Radiotherapy Drug: Temozolomide Radiation: hypofractionated radiotherapy Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients were randomized to 2 parallel groups, namely the concurrent chemoradiotherapy group and radiotherapy alone group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : December 3, 2022
Estimated Study Completion Date : December 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CRT group
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
Drug: Temozolomide
75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.

Radiation: hypofractionated radiotherapy
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.

Active Comparator: RT group
patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
Radiation: hypofractionated radiotherapy
the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.




Primary Outcome Measures :
  1. intracranial progression free survival (IPFS) rate [ Time Frame: up to 2 years ]
    IPFS was defined as the interval from the beginning of radiation to any intracranial progression


Secondary Outcome Measures :
  1. local control rate [ Time Frame: up to 2 years ]
    the control rate of treated lesions

  2. Brain metastasis-specific survival (BMSS) rate [ Time Frame: up to 2 years ]
    BMSS was defined as the internal from the beginning of RT to death caused by BM

  3. overall survival (OS) rate [ Time Frame: up to 2 years ]
    OS was defined as the internal from the beginning of RT to death caused by any reason

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria [ Time Frame: acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT ]
    the toxicities caused by RT and (or) Chemotherapy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778541


Contacts
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Contact: Jianping Xiao, Dr +8613811026919 jpxiao8@163.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Jianping Xiao, Dr    86-13811026919    jpxiao8@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Jianping Xiao, Dr Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Jianping Xiao, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03778541    
Other Study ID Numbers: LBM-RCT
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents