LET Optimeret IMPT til behandling af pædiatriske patienter med ependymom
Pilotforsøg med LET-optimeret IMPT til pædiatriske patienter med ependymom
This phase I trial studies the side effects of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) in treating pediatric patients with ependymoma. Radiation therapy such as LET optimized IMPT, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate the safety of linear energy transfer (LET) optimized image modulated proton therapy (IMPT) (bio-IMPT) for pediatric patients with ependymoma.
SECONDARY OBJECTIVES:
I. To utilize advanced multiparametric magnetic resonance (MR) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients.
II. To compare quantitative image biomarkers in patients treated with bio-IMPT and standard proton therapy using a voxel level analysis.
III. To test and evaluate the validity of relative biological effectiveness (RBE) models and enhance their precision based on prospectively collected clinical image biomarkers.
IV. To evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-IMPT.
V. To estimate progression-free survival (PFS) and overall survival (OS). VI. To evaluate disease outcomes following the use of a simultaneous integrated boost (SIB) for pediatric ependymoma patients with gross residual disease following surgery.
OUTLINE:
Patients receive LET optimized IMPT for up to 6 weeks.
After completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: David Grosshans
- Telefonnummer: 713-563-2300
- E-mail: dgrossha@mdanderson.org
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Ikke rekrutterer endnu
- Massachusetts General Hospital Cancer Center
-
Kontakt:
- Kaden L Mitra Litzinger
- E-mail: klitzinger@mgh.harvard.edu
-
Ledende efterforsker:
- Torunn Yock
-
-
Texas
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- M D Anderson Cancer Center
-
Kontakt:
- David R. Grosshans
- Telefonnummer: 713-563-2300
-
Ledende efterforsker:
- David R. Grosshans
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Previous pathologic confirmation of ependymoma, World Health Organization (WHO) grade II or III
- Disease must be confined to the brain (no evidence of spread on MR imaging of the spine or on staging lumbar puncture)
- Patient may not receive chemotherapy concurrent with radiation
- Signed informed consent by patient and/or parents or legal guardian
- Lansky performance status score of 50 -100
Exclusion Criteria:
- Patients with previous radiation therapy to the brain
- Ependymoma of the spine
- Disseminated ependymoma requiring craniospinal radiation therapy
- Pregnancy
- Inability to undergo MR imaging
- Inability to receive gadolinium-based contrast agent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment (LET optimized IMPT)
Patients receive LET optimized IMPT for up to 6 weeks. |
Ancillary studies
Andre navne:
Ancillary studies Given LET optimized IMPT
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of adverse events
Tidsramme: Up to 6 months post treatment
|
The safety of linear energy transfer-optimized intensity modulated proton therapy will be defined by treatment failures which include imaging changes consistent with necrosis in the presence of Common Terminology Criteria for Adverse Events version 4.03 symptoms of grade 3 brain necrosis and/or local recurrence within the first 6 months from the end of proton therapy. |
Up to 6 months post treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Identify imaging biomarkers of structural and biological changes after proton therapy
Tidsramme: Up to 24 months post-treatment
|
Descriptive statistics will be used to summarize the study data. |
Up to 24 months post-treatment
|
|
Quantitative image biomarkers
Tidsramme: Up to 24 months post-treatment
|
Descriptive statistics will be used to summarize the study data. |
Up to 24 months post-treatment
|
|
Validity of relative biological effectiveness models
Tidsramme: Up to 24 months post-treatment
|
Descriptive statistics will be used to summarize the study data. |
Up to 24 months post-treatment
|
|
Incidence of late and acute toxicities
Tidsramme: Up to 24 months post treatment
|
Descriptive statistics will be used to summarize the study data. For each study cohort, we will tabulate treatment- failures and other relevant clinically-related features. Interval estimates for proportions will be provided using exact 95% confidence intervals. |
Up to 24 months post treatment
|
|
Progression-free survival
Tidsramme: Up to 24 months post treatment
|
The method of Kaplan and Meier will be used to provide estimates. |
Up to 24 months post treatment
|
|
Overall survival
Tidsramme: Up to 24 months post treatment
|
The method of Kaplan and Meier will be used to provide estimates. |
Up to 24 months post treatment
|
|
Disease outcomes following the use of a simultaneous integrated boost
Tidsramme: Up to 24 months post-treatment
|
Descriptive statistics will be used to summarize the study data. |
Up to 24 months post-treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: David R Grosshans, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Gliom
- Neoplasmer, Neuroepithelial
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Ependymom
- Fysiske fænomener
- Biokemiske fænomener
- Kemiske fænomener
- Energi Overførsel
- Biofysiske Fænomener
- Lineær Energioverførsel
Andre undersøgelses-id-numre
- 2018-0344
- P30CA016672 (U.S. NIH-bevilling/kontrakt)
- 2018-0344 (Anden identifikator: M D Anderson Cancer Center)
- NCI-2018-02519 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U19CA021239 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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