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Recurrent Diffuse Intrinsic Pontine GliomaNCT03841435

Hypofractionated Radiotherapy for Recurrent DIPG

A study testing Hypofractionated Radiotherapy in people with Recurrent Diffuse Intrinsic Pontine Glioma, run by University of Cincinnati at 1 site in United States.

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

This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions. Read more about this study

Who is it for?
Ages Up to 30 years
What is being tested?
Hypofractionated Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
31 Jan 2018to 3 Mar 2023
Phase
Interventional
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 Up to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must be ≤30 years of age
  • Patients must have a diagnosis of progressive DIPG.
  • Received prior IMRT based definitive radiotherapy to a dose of ≥54 Gy.
  • The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition.
  • Steroids dosage must be unchanged for 5 days.
  • No Bevacizumab within 21 days (Half-life 11 days ~)

Who cannot join

  • Patients with incomplete medical records
  • Patients with prior history of reirradiation for DIPG
  • Life expectancy < or equal to 1 month
  • Pregnant women
  • Age >30
  • Prisoners
Show all 9Show fewer
  • Concurrent systemic therapy at the time of reirradiation
  • Physically or mentally incapable of signing the consent form of their own volition
  • < 6 mos time interval between completion of initial RT to start of reRT.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Cincinnati

    Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma

This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.

Being tested
Hypofractionated Radiotherapy
Medical subject headings
Diffuse Intrinsic Pontine Glioma

What participants receive

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

  • Hypofractionated RadiotherapyRadiation

    Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.

Study groups in NCT03841435
Study groupRoleWhat they receive
Hypofractionated RadiotherapyExperimental15 Gy given in 3 fractions over 2 weeks
Receives: Radiation: Hypofractionated Radiotherapy

What is being measured

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

  1. Post Radiation Toxicity

    RTOG common toxicity criteria grade 0-5

    Measured: Through Study Completion, an average of 1 year

Secondary outcomes (5)

  1. Change in Quality of Life score

    Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0

    Measured: Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT

  2. Radiographic Response

    Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI

    Measured: 1 month

  3. Progression Free Survival

    Time to clinical, symptomatic or radiographic evidence of disease progression

    Measured: Through Study Completion, an average of 1 year

  4. Overall Survival

    Time to patient death

    Measured: Through Study Completion, an average of 1 year

  5. Steroid Requirement

    Use of steroids post-RT

    Measured: Through Study Completion, an average of 1 year

Timeline

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

  1. First posted15 Feb 2019
  2. Study start31 Jan 2018
  3. Primary completion3 Mar 2023
  4. Study completion3 Mar 2023

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 N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841435
Sponsor's protocol ID
2017-2183
Status last verified
Sep 2023
First submitted
12 Feb 2019
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will be kept confidential and will not be shared with other researchers

Publications

  • Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available.

    PubMed 24137015

  • Vanan MI, Eisenstat DD. DIPG in Children - What Can We Learn from the Past? Front Oncol. 2015 Oct 21;5:237. doi: 10.3389/fonc.2015.00237. eCollection 2015.

    PubMed 26557503

  • Fangusaro J. Pediatric high-grade gliomas and diffuse intrinsic pontine gliomas. J Child Neurol. 2009 Nov;24(11):1409-17. doi: 10.1177/0883073809338960. Epub 2009 Jul 28.

    PubMed 19638636

  • Fontanilla HP, Pinnix CC, Ketonen LM, Woo SY, Vats TS, Rytting ME, Wolff JE, Mahajan A. Palliative reirradiation for progressive diffuse intrinsic pontine glioma. Am J Clin Oncol. 2012 Feb;35(1):51-7. doi: 10.1097/COC.0b013e318201a2b7.

    PubMed 21297433

  • Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037.

    PubMed 18406885

  • Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982.

    PubMed 19260098

  • Bouffet E, Hawkins CE, Ballourah W, Taylor MD, Bartels UK, Schoenhoff N, Tsangaris E, Huang A, Kulkarni A, Mabbot DJ, Laperriere N, Tabori U. Survival benefit for pediatric patients with recurrent ependymoma treated with reirradiation. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):1541-8. doi: 10.1016/j.ijrobp.2011.10.039. Epub 2012 Jan 13.

    PubMed 22245198

  • Iqbal MS, Lewis J. An overview of the management of adult ependymomas with emphasis on relapsed disease. Clin Oncol (R Coll Radiol). 2013 Dec;25(12):726-33. doi: 10.1016/j.clon.2013.07.009. Epub 2013 Aug 20.

    PubMed 23972764

  • Mayer R, Sminia P. Reirradiation tolerance of the human brain. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1350-60. doi: 10.1016/j.ijrobp.2007.08.015. Epub 2007 Nov 26.

    PubMed 18037587

  • Massimino M, Biassoni V, Miceli R, Schiavello E, Warmuth-Metz M, Modena P, Casanova M, Pecori E, Giangaspero F, Antonelli M, Buttarelli FR, Potepan P, Pollo B, Nunziata R, Spreafico F, Podda M, Anichini A, Clerici CA, Sardi I, De Cecco L, Bode U, Bach F, Gandola L. Results of nimotuzumab and vinorelbine, radiation and re-irradiation for diffuse pontine glioma in childhood. J Neurooncol. 2014 Jun;118(2):305-312. doi: 10.1007/s11060-014-1428-z. Epub 2014 Apr 3.

    PubMed 24696052

  • Lassaletta A, Bartels U, Strother D, et al. Hg-57re-irradiation in patients with diffuse intrinsic pontine gliomas, an update on the canadian experience. Neuro-Oncology 2016;18:iii60-iii61.

  • Freese C, Takiar V, Fouladi M, DeWire M, Breneman J, Pater L. Radiation and subsequent reirradiation outcomes in the treatment of diffuse intrinsic pontine glioma and a systematic review of the reirradiation literature. Pract Radiat Oncol. 2017 Mar-Apr;7(2):86-92. doi: 10.1016/j.prro.2016.11.005. Epub 2016 Nov 23.

    PubMed 28274399

  • Hoffman LM, Plimpton SR, Foreman NK, Stence NV, Hankinson TC, Handler MH, Hemenway MS, Vibhakar R, Liu AK. Fractionated stereotactic radiosurgery for recurrent ependymoma in children. J Neurooncol. 2014 Jan;116(1):107-11. doi: 10.1007/s11060-013-1259-3.

    PubMed 24078173

  • Mayo C, Yorke E, Merchant TE. Radiation associated brainstem injury. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S36-41. doi: 10.1016/j.ijrobp.2009.08.078.

    PubMed 20171516

  • Freeman CR, Krischer JP, Sanford RA, Cohen ME, Burger PC, del Carpio R, Halperin EC, Munoz L, Friedman HS, Kun LE. Final results of a study of escalating doses of hyperfractionated radiotherapy in brain stem tumors in children: a Pediatric Oncology Group study. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):197-206. doi: 10.1016/0360-3016(93)90228-n.

    PubMed 8407392

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated Radiotherapy in people with Recurrent Diffuse Intrinsic Pontine Glioma, run by University of Cincinnati at 1 site in United States.

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 6 inclusion and 9 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 13 Sep 2023. 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 United States. 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.

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?

Post Radiation Toxicity (time frame: Through Study Completion, an average of 1 year). 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 NCT03841435, which also lists 17 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 13 Sep 2023.

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