HFSRT With Concurrent TMZ for Large BMs

NCT03778541 | Unknown Phase 3

• 1 other identifier: LBM-RCT
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• intracranial progression free survival (IPFS) rate

  IPFS was defined as the interval from the beginning of radiation to any intracranial progression

  up to 2 years

Secondary Outcomes (4)

• local control rate

  up to 2 years

• Brain metastasis-specific survival (BMSS) rate

  up to 2 years

• overall survival (OS) rate

  up to 2 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 and NRG/RTOG CNS toxicities criteria

  acute toxicities: up to 3 months after RT; Late toxicities: up to 2 years after RT

Study Arms (2)

CRT group

EXPERIMENTAL

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

Drug: Temozolomide; Radiation: hypofractionated radiotherapy

RT group

ACTIVE COMPARATOR

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

Radiation: hypofractionated radiotherapy

Interventions

Temozolomide DRUG

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

CRT group

hypofractionated radiotherapy RADIATION

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

CRT group; RT group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Temozolomide; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Jianping Xiao, Dr

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianping Xiao, Dr

CONTACT

+8613811026919; jpxiao8@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 19, 2018
• Study Start: December 3, 2018
• Primary Completion: December 3, 2022
• Study Completion: December 3, 2022
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)