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Recurrent Glioblastoma MultiformePhase 2GBM Hypo RTNCT01464177

Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

A Phase 2 study testing Stereotactic hypofractionated RT 5x5Gy and Stereotactic hypofractionated RT 5x7Gy in people with Recurrent Glioblastoma Multiforme, run by Andre Tsin Chih Chen at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma Multiforme
What is being tested?
Stereotactic hypofractionated RT 5x5Gy and Stereotactic hypofractionated RT 5x7Gy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
Oct 2011to Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • KPS equal or greater than 60
  • Anatomopathological confirmation of GBM
  • Previous RT with therapeutic doses
  • At least 5 months from the end of RT course
  • Not a candidate to surgical resection
Show all 10Show fewer
  • Patients with partial resection after resection of recurrent GBM will be allowed
  • Patients with local progression after resection of recurrent GBM will be allowed
  • Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
  • Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.

Who cannot join

  • Important comorbidities
  • Concomitant chemotherapy
  • Contraindication to MRI
  • Brainstem glioma

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

Official title: Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme

Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009).

The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases.

The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.

Being tested
Stereotactic hypofractionated RT 5x5Gy, Stereotactic hypofractionated RT 5x7Gy
Keywords
malignant glioma, glioblastoma, radiotherapy, randomized
Medical subject headings
Glioblastoma, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic hypofractionated RT 5x5GyRadiation

    Stereotactic hypofractionated radiation therapy delivered as follows:

    • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
    • Planning tumor volume (PTV) equals GTV plus 3mm margin.
    • The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
    • RT to begin in a maximum of 2 weeks after randomization

  • Stereotactic hypofractionated RT 5x7GyRadiation

    Stereotactic hypofractionated radiation therapy delivered as follows:

    • Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
    • Planning tumor volume (PTV) equals GTV plus 3mm margin.
    • The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
    • RT to begin in a maximum of 2 weeks after randomization.
Study groups in NCT01464177
Study groupRoleWhat they receive
Stereotactic hypofractionated RT 5x5GyActive comparatorStereotactic hypofractionated radiation therapy delivered as follows: * Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI. * Planning tumor volume (PTV) equals GTV plus 3mm margin. * the dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days. * RT to begin in a maximum of 2 weeks after randomization.
Receives: Radiation: Stereotactic hypofractionated RT 5x5Gy
Stereotactic hypofractionated RT 5x7GyExperimentalStereotactic hypofractionated radiation therapy delivered as follows: * Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI. * Planning tumor volume (PTV) equals GTV plus 3mm margin. * the dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days. * RT to begin in a maximum of 2 weeks after randomization.
Receives: Radiation: Stereotactic hypofractionated RT 5x7Gy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    progression free survival as defined by the "Response Assesment in Neuro Oncology Working Group"(Wen, 2010). Briefly progression is defined as:

    • increase in 25% of the product of perpendicular diameters of enhancing lesions
    • significant increase in T2/Flair non enhancing component
    • appearance of new lesions
    • clinical deterioration not attributable to other causes other than the tumor or reduction in corticosteroid dose

    Measured: from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months

Secondary outcomes (4)

  1. overall survival

    Measured: from date of randomization until death from any cause, assessed up to 48 months

  2. local control

    Measured: from date of randomization until date of local progression, assessed up to 48 months

  3. toxicity

    • toxicity scored by the Common Terminology of Adverse Events version 4
    • will be assessed every 2 months or in case of patient hospitalization or visit to the E.R.

    Measured: from date of randomization until death, assessed up to 48 months

  4. quality of life

    • quality of life measured by the "FACT Br" questionary
    • will be assessed every 2 months

    Measured: from date of randomization until last follow-up, assessed up to a period of 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJul 2021
  4. Study completionAug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464177
Sponsor's protocol ID
RT-01/2011
Acronym
GBM Hypo RT
Status last verified
Dec 2024
First submitted
25 Oct 2011
Last updated
9 Dec 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PubMed 15758009

  • Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.

    PubMed 19269895

  • Niyazi M, Siefert A, Schwarz SB, Ganswindt U, Kreth FW, Tonn JC, Belka C. Therapeutic options for recurrent malignant glioma. Radiother Oncol. 2011 Jan;98(1):1-14. doi: 10.1016/j.radonc.2010.11.006. Epub 2010 Dec 13.

    PubMed 21159396

  • Shepherd SF, Laing RW, Cosgrove VP, Warrington AP, Hines F, Ashley SE, Brada M. Hypofractionated stereotactic radiotherapy in the management of recurrent glioma. Int J Radiat Oncol Biol Phys. 1997 Jan 15;37(2):393-8. doi: 10.1016/s0360-3016(96)00455-5.

    PubMed 9069312

  • Vordermark D, Kolbl O, Ruprecht K, Vince GH, Bratengeier K, Flentje M. Hypofractionated stereotactic re-irradiation: treatment option in recurrent malignant glioma. BMC Cancer. 2005 May 30;5:55. doi: 10.1186/1471-2407-5-55.

    PubMed 15924621

  • Ernst-Stecken A, Ganslandt O, Lambrecht U, Sauer R, Grabenbauer G. Survival and quality of life after hypofractionated stereotactic radiotherapy for recurrent malignant glioma. J Neurooncol. 2007 Feb;81(3):287-94. doi: 10.1007/s11060-006-9231-0. Epub 2006 Sep 20.

    PubMed 17031558

  • Fogh SE, Andrews DW, Glass J, Curran W, Glass C, Champ C, Evans JJ, Hyslop T, Pequignot E, Downes B, Comber E, Maltenfort M, Dicker AP, Werner-Wasik M. Hypofractionated stereotactic radiation therapy: an effective therapy for recurrent high-grade gliomas. J Clin Oncol. 2010 Jun 20;28(18):3048-53. doi: 10.1200/JCO.2009.25.6941. Epub 2010 May 17.

    PubMed 20479391

  • Fokas E, Wacker U, Gross MW, Henzel M, Encheva E, Engenhart-Cabillic R. Hypofractionated stereotactic reirradiation of recurrent glioblastomas : a beneficial treatment option after high-dose radiotherapy? Strahlenther Onkol. 2009 Apr;185(4):235-40. doi: 10.1007/s00066-009-1753-x. Epub 2009 Apr 16.

    PubMed 19370426

  • Cheng JX, Zhang X, Liu BL. Health-related quality of life in patients with high-grade glioma. Neuro Oncol. 2009 Feb;11(1):41-50. doi: 10.1215/15228517-2008-050. Epub 2008 Jul 15.

    PubMed 18628405

  • Liu R, Page M, Solheim K, Fox S, Chang SM. Quality of life in adults with brain tumors: current knowledge and future directions. Neuro Oncol. 2009 Jun;11(3):330-9. doi: 10.1215/15228517-2008-093. Epub 2008 Nov 10.

    PubMed 19001097

  • Wen PY, Macdonald DR, Reardon DA, Cloughesy TF, Sorensen AG, Galanis E, Degroot J, Wick W, Gilbert MR, Lassman AB, Tsien C, Mikkelsen T, Wong ET, Chamberlain MC, Stupp R, Lamborn KR, Vogelbaum MA, van den Bent MJ, Chang SM. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010 Apr 10;28(11):1963-72. doi: 10.1200/JCO.2009.26.3541. Epub 2010 Mar 15.

    PubMed 20231676

  • Chen ATC, Serante AR, Ayres AS, Tonaki JO, Moreno RA, Shih H, Gattas GS, Lopez RVM, Dos Santos de Jesus GR, de Carvalho IT, Marotta RC, Marta GN, Feher O, Neto HS, Ribeiro ISN, Vasconcelos KGMDC, Figueiredo EG, Weltman E. Prospective Randomized Phase 2 Trial of Hypofractionated Stereotactic Radiation Therapy of 25 Gy in 5 Fractions Compared With 35 Gy in 5 Fractions in the Reirradiation of Recurrent Glioblastoma. Int J Radiat Oncol Biol Phys. 2024 Jul 15;119(4):1122-1132. doi: 10.1016/j.ijrobp.2024.01.013. Epub 2024 Jan 15.

    PubMed 38232937

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic hypofractionated RT 5x5Gy and Stereotactic hypofractionated RT 5x7Gy in people with Recurrent Glioblastoma Multiforme, run by Andre Tsin Chih Chen at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: from date of randomization until date of first documented progression or death from any cause, which ever comes first, assessed up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464177, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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