Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

NCT01702610 | Completed

• 2 other identifiers: GEN-08-013MGRT01:TMZ/GBM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with GBM, who were deemed ineligible for any active protocols at our centre, received accelerated hypofractionation EBRT if 60Gy/20Fx using an IMRT technique with conventional dose of concomitant and adjuvant TMX as per the STUPP's TMZ schedule. Thirty five patients, 15 females and 20 males with a median age of 63 (range 31-78) were treated with a median KPS of 90 (range 50-100). Four patients had multicentric disease at presentation. Eight patients had biopsy only while the rest had a near total resection (n=14) and partial resection (n=13) with a median follow-up of 12.1 months, the median survival was 14.4 months.

Conditions

Glioblastoma Mutliforme

Outcome Measures

Primary Outcomes (2)

• Percent of patients completing the study treatment

  To determine overall survival.

  At one year

• To assess toxicity of the regimen

  Toxicity will be assessed and graded according to CTCAE-V3

  At one year

Study Arms (1)

Temozolomide, Accelerated Hypofractionated RT

EXPERIMENTAL

Patient will receive two weeks of neo-adjuvant Temozolomide followed by Accelerated Hypofractionated RT for a total of 20 fractions for a total of 60Gy followed by Temozolomide for 12 cycles.

Radiation: IMRT Technique; Radiation: IMRT and accelerated hypofractionation technique; Radiation: neo-adjuvant TMZ followed by accelerated hypofractionated EBRT; Drug: Temozolomide and Accelerated Hypofractionation RT

Interventions

IMRT Technique RADIATION

Temozolomide, Accelerated Hypofractionated RT

IMRT and accelerated hypofractionation technique RADIATION

Intervention is the technique and accelerated fractionation used to treat GBM

Temozolomide, Accelerated Hypofractionated RT

neo-adjuvant TMZ followed by accelerated hypofractionated EBRT RADIATION

Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component

Temozolomide, Accelerated Hypofractionated RT

Temozolomide and Accelerated Hypofractionation RT DRUG

Temozolomide, Accelerated Hypofractionated RT

Eligibility Criteria

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

You may qualify if:

• Age: 18 years or older
• Histological confirmation of supratentorial GBM
• KPS \> 60
• Neurological function 0 or 1
• Adequate bone marrow as defined below:
• absolute neutrophil count (ANC) \> 1500 cells/mm3
• platelets \> 100,000 cells/mm3
• hemoglobin \> 10g/dl
• Adequate renal function as defined below:
• BUN \< 25mg/dl within 14 days prior to study registration
• creatinine of 63 to 103 umol/L within 14 days prior to study registration
• Adequate hepatic function as defined below:
• Bilirubin of 3 to 21 umol/L within 14 days prior to study registration
• ALT \& AST \< 3xnormal range within 14 days prior to study registration
• Neoadjuvant TMZ to start within 3 weeks of surgery/biopsy if no resection was deemed feasible

You may not qualify if:

• Margin of contrast-enhanced residual mass closer than 15mm from the optic chiasm or optic nerves.
• Prior invasive malignancy, unless disease-free for \>3years
• Recurrent or multifocal GBM
• Severe co-morbidities such as
• unstable angina
• transmural myocardial infarction within 6 months
• COPD at the time of registration
• Hepatic insufficiency
• Bacterial or fungal infection requiring IV antibiotics at the time of registration
• Acquired Immune Deficiency Syndrome (AIDS)
• Major medical illnesses or psychiatric impairments
• Pregnant women or lactating women

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• Shenouda G, Souhami L, Petrecca K, Owen S, Panet-Raymond V, Guiot MC, Corredor AG, Abdulkarim B. A Phase 2 Trial of Neoadjuvant Temozolomide Followed by Hypofractionated Accelerated Radiation Therapy With Concurrent and Adjuvant Temozolomide for Patients With Glioblastoma. Int J Radiat Oncol Biol Phys. 2017 Mar 1;97(3):487-494. doi: 10.1016/j.ijrobp.2016.11.006. Epub 2016 Nov 15.

  PMID: 28011051 DERIVED

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated; Temozolomide

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: October 8, 2012
• Study Start: December 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

CA (1)