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Hypofractionated Radiation Therapy for Glioblastoma

Primary Purpose

Glioblastoma Multiforme

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Hypofractionated radiation therapy
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSPRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypofractionated radiation therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival
From date of the start of treatment to date of death due to any cause.

Secondary Outcome Measures

Progression-free survival
The time between the start of treatment and tumor progression or death due to any cause.

Full Information

First Posted
July 5, 2017
Last Updated
July 7, 2017
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03212235
Brief Title
Hypofractionated Radiation Therapy for Glioblastoma
Official Title
Hypofractionated Radiation Therapy Plus Concomitant and Adjuvant Temozolomide for Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypofractionated radiation therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiation therapy
Intervention Description
Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)
Primary Outcome Measure Information:
Title
Overall survival
Description
From date of the start of treatment to date of death due to any cause.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
The time between the start of treatment and tumor progression or death due to any cause.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gustavo N Marta, PhD
Phone
551138934538
Email
gustavo.marta@hc.fm.usp.br
Facility Information:
Facility Name
Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo N Marta, PhD
Phone
55+11+38934538
Email
gustavo.marta@hc.fm.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypofractionated Radiation Therapy for Glioblastoma

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