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Radiochirurgia stereotassica a singola frazione rispetto alla radiochirurgia stereotassica frazionata per il trattamento della malattia cerebrale metastatica intatta, studio FRACTIONATE

29 settembre 2026 aggiornato da: Mayo Clinic

Prova di fase IIR della radiochirurgia stereotassica a singola frazione (SRS) rispetto alla SRS frazionata (FSRS) per la malattia cerebrale metastatica intatta (FRACTIONATE)

This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVE:

I. To ascertain if the composite endpoint of cumulative treatment failure, defined by time to either local failure or symptomatic radiation brain necrosis of the largest brain metastasis (target lesion), is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).

SECONDARY OBJECTIVES:

I. To ascertain whether there is improved overall survival in patients who undergo FSRS compared to patients who receive SSRS.

II. To tabulate and descriptively compare the post-treatment adverse events associated with the interventions, including the potential impact of immunotherapy and targeted therapy.

III. To compare rates of radiation necrosis in patients who receive FSRS to patients who receive SSRS.

IV. To evaluate if there is any difference in central nervous system (CNS) failure patterns (e.g. local, distant brain failure) in patients who receive FSRS compared to patients who receive SSRS.

V. To ascertain whether FSRS prolongs time to neurologic death as compared to SRS.

VI. To determine whether there is improved patient reported outcomes (Functional Assessment of Cancer Therapy [FACT]-Brain Symptom Index [FBrSI]-24) including quality of life for patients who receive FSRS compared to patients who receive SSRS.

VII. To evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) and symptomatic radiation necrosis rates in patients who are treated with gamma knife compared to patients who are treated with a linear accelerator platform.

VIII. To determine whether differences in time to local failure, time to necrosis, or their composite endpoint cumulative treatment failure differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo single fraction SRS. Patients also undergo magnetic resonance imaging (MRI) at screening and during follow up.

ARM B: Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days. Patients also undergo MRI at screening and during follow up.

After completion of study treatment, patients are followed up at 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85259
        • Reclutamento
        • Mayo Clinic in Arizona
        • Contatto:
        • Investigatore principale:
          • Sujay A. Vora, MD
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224
        • Reclutamento
        • Mayo Clinic in Florida
        • Contatto:
        • Investigatore principale:
          • Jennifer L. Peterson, MD
    • Minnesota
      • Albert Lea, Minnesota, Stati Uniti, 56007
        • Non ancora reclutamento
        • Mayo Clinic Health System in Albert Lea
        • Contatto:
        • Investigatore principale:
          • John Yeakel, MD
        • Contatto:
      • Mankato, Minnesota, Stati Uniti, 56001
        • Reclutamento
        • Mayo Clinic Health Systems-Mankato
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Jason T. Hayes, MD
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Mayo Clinic in Rochester
        • Investigatore principale:
          • Paul D. Brown, M.D.
        • Contatto:
    • Wisconsin
      • Eau Claire, Wisconsin, Stati Uniti, 54701
        • Reclutamento
        • Mayo Clinic Health System-Eau Claire Clinic
        • Contatto:
        • Investigatore principale:
          • Now Bahar Alam, MD
        • Contatto:
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Reclutamento
        • Mayo Clinic Health System-Franciscan Healthcare
        • Contatto:
        • Investigatore principale:
          • Abigail L. Stockham, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age >= 18 years old

  • Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)

    • Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible

  • Size of brain metastases

    • At least one intact metastasis (not previously treated with radiosurgery) must measure >= 2.0 cm and =< 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =< 28 days prior to registration
    • If the largest lesion measures >= 2.0 to =< 4.0 cm in maximal extent the patient will be randomized

  • Able to undergo contrast enhanced MRI brain

  • Negative urine or serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only

  • Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.

  • Karnofsky performance status (KPS) >= 50

  • Eastern Cooperative Oncology Group (ECOG) performance score of (PS) >= 2

  • Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations

    • Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol

Exclusion Criteria:

  • Any patient who has received previous whole brain radiation

  • Any brain metastasis that is located in the brainstem measuring >= 2.0 cm in maximal extent

  • Any patient with definitive evidence of leptomeningeal metastasis (LMD)

    • NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion

  • Any patient with an intact brain metastasis measuring > 4.0 cm

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Arm A (single fraction SRS)

Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Imaging medico
  • Risonanza Magnetica / Risonanza Magnetica Nucleare
  • risonanza magnetica nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Radiazione: Stereotactic Radiosurgery

Undergo single fraction SRS

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS
Radiazione: Stereotactic Radiosurgery

Undergo fractionated SRS

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS
Altro: Arm B (fractionated SRS)

Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Imaging medico
  • Risonanza Magnetica / Risonanza Magnetica Nucleare
  • risonanza magnetica nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Radiazione: Stereotactic Radiosurgery

Undergo single fraction SRS

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS
Radiazione: Stereotactic Radiosurgery

Undergo fractionated SRS

Altri nomi:
  • Irradiazione esterna stereotassica del raggio
  • radioterapia stereotassica a fasci esterni
  • Radioterapia stereotassica
  • radioterapia stereotassica
  • radiochirurgia stereotassica
  • SRS

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
Lasso di tempo: Up to 5 years

Will determine if the composite endpoint of time to local failure or symptomatic radiation brain necrosis of a large brain metastasis [cumulative treatment failure (CTF)] is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).
Up to 5 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: From study entry to death from any cause, assessed up to 5 years

OS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. Medians and 95% confidence intervals will be reported.
From study entry to death from any cause, assessed up to 5 years
Incidence of adverse events
Lasso di tempo: Up to 2 years post radiation therapy

The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 2 years post radiation therapy
Rates of radiation necrosis
Lasso di tempo: Up to 5 years

Will compare rates of radiation necrosis in patients who receive FSRS to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Central nervous system (CNS) failure patterns (Fractionation)
Lasso di tempo: Up to 5 years

Will evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) in patients who receive FSRS compared to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Time to neurologic death
Lasso di tempo: Up to 5 years

Will ascertain whether FSRS prolongs time to neurologic death as compared to SSRS. This will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. Medians and 95% confidence intervals will be reported.
Up to 5 years
Quality of life (QOL)
Lasso di tempo: Up to 5 years

Will determine whether there are improved patient reported outcomes (Functional Assessment of Cancer Therapy [FACT]-Brain Symptom Index [FBrSI]-24) including quality of life for patients who receive FSRS compared to patients who receive SSRS. Changes over time in QOL from baseline will be compared between arms using the 2-sample t-test (or Wilcoxon Rank-Sum test for non-normal data). Box-plots will be used to show differences between arms graphically.
Up to 5 years
CNS failure patterns (Gamma Knife)
Lasso di tempo: Up to 5 years

Will evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) and symptomatic radiation necrosis rates in patients who are treated with Gamma Knife compared to patients who are treated with a linear accelerator platform. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Up to 5 years
Per lesion analysis between treatment arms: time to local failure
Lasso di tempo: Up to 5 years

Will determine whether differences in time to local failure differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years
Per lesion analysis between treatment arms: time to necrosis
Lasso di tempo: Up to 5 years

Will determine whether differences in time to necrosis differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years
Per lesion analysis between treatment arms: endpoint CTF
Lasso di tempo: Up to 5 years

Will determine whether differences in the composite endpoint CTF differs between treatment arms (or other patient or treatment factors) when analyzed on a "per lesion" basis rather than the per patient basis utilized for the primary endpoint. Time-to-event models (Cox and Kaplan- Meier) with sandwich estimators for covariance will be utilized to in treatment comparisons, with model comparisons completed through log-likelihood and Akaike Information Criterion.
Up to 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mayo Clinic

Investigatori

  • Investigatore principale: Paul D. Brown, MD, Mayo Clinic in Rochester

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 marzo 2022

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

11 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

24 gennaio 2022

Primo Inserito (Effettivo)

3 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GMROR2163
  • NCI-2021-14230 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • 21-003768 (Altro identificatore: Mayo Clinic Institutional Review Board)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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