Hypofractionated Radiation Therapy for Glioblastoma

NCT ID: NCT03212235

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2020-06-01

Brief Summary

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Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.

Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionated radiation therapy

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week.

After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.

Group Type EXPERIMENTAL

Hypofractionated radiation therapy

Intervention Type RADIATION

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

Interventions

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Hypofractionated radiation therapy

Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
* WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.

Exclusion Criteria

* Prior diagnosis of cancer, unless disease free for \> 3 years
* Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
* Specific severe, active co-morbidities
* Tumor located in the brainstem
* Presence of leptomeningeal carcinomatosis
* Multicentric tumor
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Gustavo Nader Marta

Radiation Oncologist and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Gustavo N Marta, PhD

Role: CONTACT

551138934538

Facility Contacts

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Gustavo N Marta, PhD

Role: primary

55+11+38934538

Other Identifiers

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Hypofractionated GBM

Identifier Type: -

Identifier Source: org_study_id

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