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Completed

NCT Number: NCT04178330

Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases

This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy as primary radiotherapy for multiple brain metastases(≥3 lesions).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;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 organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 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 WBRT. Pregnant patients or female patients whose HCG is positive. Unsuitable to participate in study, that in the opinion of the treating physician.

Treatment and study plan

Tomotherapy

Radiation

Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.

Primary outcomes

  1. Disease control rate(DCR)

    Time frame: 2-3 month after radiation

    Using RTOG9508 criteria, tumor control is defined as CR+PR+SD

Secondary outcomes

  1. Overall survival

    Time frame: up to 3 years

    the time from radiation to death

  2. progress free survival

    Time frame: up to 1 year

    the time from radiation to any progression

  3. local control rate

    Time frame: up to 1 year

    the time from radiation to the treated brain metastases recurrence

  4. intracranial progress free survival rate

    Time frame: up to 1 year

    the time from radiation to local recurrence and/or new brain metastases

  5. adverse event

    Time frame: from the day of radiation, up to 3 years

    acute and late toxicities

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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