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Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

3. januar 2021 oppdatert av: Shannon MacDonald, MD, Massachusetts General Hospital

Craniospinal Irradiation Using Proton Beam Scanning With Selective Vertebral Body/Bone Sparing to Improve Marrow Reserve and Decrease Growth Decrement for Children

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation.

The radiation involved in this study is:

-Proton Radiation

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This research study is a Pilot Study to determine whether using proton therapy in participants that require craniospinal radiation (whole brain and spinal cord radiation therapy) with sparing of the bony spine will work. This is the first time investigators are examining bone sparing proton therapy in pediatric craniospinal radiation.

The FDA (the U.S. Food and Drug Administration) has not approved proton radiation for this specific disease but it has been approved for other uses.

In this research study, the investigators are studying proton radiation in participants that require craniospinal radiation. The standard of care for this procedure is photon radiation, which is very similar to proton radiation. The investigators believe that the precision of proton radiation may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Studietype

Intervensjonell

Registrering (Forventet)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02214
        • Rekruttering
        • Massachusetts General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Shannon MacDonald, MD
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • MD Anderson Cancer Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Susan McGovern, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 3 years and ≤ 18 years at the time of registration
  • Histologically proven malignancy necessitating cranio-spinal irradiation. This will include patients with a diagnosis of medulloblastoma, Supratentorial primitive neuroectodermal tumor (SPNET), germ cell tumor (GCT), disseminated ependymoma, embryonal tumor with abundant neuropil and true rosettes (ETANTR), Atypical Teratoid/Rhabdoid Tumor (ATRT), and disseminated low-grade glioma (LGG).
  • Life expectancy ≥ 12 months.
  • Signed informed consent document and assent when appropriate.
  • HGB of > 10 g/L and PLT count > 80 K/uL

Exclusion Criteria:

  • Any prior therapeutic radiation therapy > 500 cGy has been delivered.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances: if they have been disease-free for at least 5 years and are deemed by the investigator to be a low-risk for recurrence of that malignancy; or, have had only cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.
  • Any major uncontrolled or poorly controlled intercurrent illness that would limit compliance with study requirements.
  • Pregnant females are excluded. Females of childbearing age/menstruating must confirm that either they are not sexually active or have a negative pregnancy test prior to initiation of radiation therapy.
  • Patients that receive concurrent chemotherapy with the exception of concurrent Vincristine.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Proton Radiotherapy
  • Patients will be treated with Proton Beam once daily 5 days per week.
  • Doses will be prescribed such that maximum possible coverage is achieved
Stråling: Proton Beam
precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of cranio-spinal irradiation (CSI) utilizing intensity-modulated proton therapy (IMPT) with pencil beam scanning (PBS) for vertebral body sparing (VBS) in pediatric patients.
Tidsramme: 3 months
IMPT using PBS delivery will be considered to be feasible as a VBS technique for CSI in pediatric patients if the rate of grade 3/4 hematologic toxicity were no more than 5% within 3 months after the completion of radiation treatment, within the range associated with conventional techniques of CSI. Toxicity will be assess using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Early marrow changes in the vertebral bodies
Tidsramme: 2 years
Summary of early marrow changes in the vertebral bodies by Magnetic resonance imaging (MRI) of the spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-RT MRI.
2 years
Vertebral column growth (measured by MRI) over 5 years
Tidsramme: Annually for 5 years
Summary of vertebral column growth (measured by MRI) over 5 years following vertebral body sparing cranio-spinal irradiation in pediatric patients.
Annually for 5 years
Change in sitting height and standing height
Tidsramme: Annually for 5 years
Summary of the changes in the participants sitting and standing heights.
Annually for 5 years
Time to abnormality in spinal curvature
Tidsramme: 5 years
Participants are monitored both clinically and by MRI for any abnormality in spinal curvature. The time to abnormality in spine curvature will be measured from the start of radiation to the date of documented abnormality or censored at the date of last follow-up for patients still alive with normal spine.
5 years
Disease Free Survival
Tidsramme: 5 years
Disease-free survival is measured from the start of radiation to the date of progressive disease based on imaging studies obtained as standard care or to the date of death due to any cause, whichever is earlier. Disease-free survival will be estimated using the Kaplan-Meier method. Patients without progressive disease and still alive will be censored at their date of last contact.
5 years
Pattern of Disease Relapse
Tidsramme: 2 years
Summary of the sites where the cancer relapses. Relapse is the regrowth of cancer cells.
2 years
Complete blood counts (CBC) over time
Tidsramme: Annually for 5 years
Summary of the change in complete blood counts (CBC) over time as determined by yearly blood samples.
Annually for 5 years
Change in levels of vitamin D, calcium, and growth hormones over time
Tidsramme: Annually for 5 years
Summary of the changes in blood levels of vitamin D, calcium, and growth hormones.
Annually for 5 years
Weight
Tidsramme: Annually for 5 years
Summary of the changes in weight of the participants as assessed by yearly evaluations.
Annually for 5 years
BMI
Tidsramme: Annually for 5 years
Summary of the body mass index (BMI) of the participants as assessed by yearly physical evaluations.
Annually for 5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Shannon MacDonald, MD, Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. januar 2018

Primær fullføring (Forventet)

31. mars 2022

Studiet fullført (Forventet)

31. mars 2025

Datoer for studieregistrering

Først innsendt

8. september 2017

Først innsendt som oppfylte QC-kriteriene

11. september 2017

Først lagt ut (Faktiske)

13. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 17-283
  • U19CA021239-37 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

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Forhold

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Legemiddelintervensjoner

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