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Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy

3 gennaio 2021 aggiornato da: Shannon MacDonald, MD, Massachusetts General Hospital

Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

70

Fase

  • Non applicabile

Contatti e Sedi

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

Luoghi di studio

  • Stati Uniti
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital

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:

  • Histologically confirmed invasive breast cancer confined to the breast and regional lymphatics
  • Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
  • Life expectancy > 12 months

Exclusion Criteria:

  • Pregnant or breast-feeding
  • Prior therapeutic radiation > 200 cGy
  • History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
  • Prior investigation chemotherapy

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: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Proton Radiation
Radiation therapy with proton beam
Radiazione: Proton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
Lasso di tempo: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Number of Participants With Acute Skin Toxicities
Lasso di tempo: From the start of treatment until 3 months after the end of treatment
Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
From the start of treatment until 3 months after the end of treatment
Rate and Severity of Radiation Pneumonitis
Lasso di tempo: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.

The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).

  • Grade 1: Mild
  • Grade 2: Moderate
  • Grade 3: Severe
  • Grade 4: Life-Threatening
  • Grade 5: Fatal
From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
Summary of Late Skin Toxicity
Lasso di tempo: From 3 months after the end of treatment up to 5 years
A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
From 3 months after the end of treatment up to 5 years
To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
Lasso di tempo: From the start of treatment until 5 years post treatment
From the start of treatment until 5 years post treatment
Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
Lasso di tempo: From the start of treatment until 5 years post treatment
Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
From the start of treatment until 5 years post treatment
The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
Lasso di tempo: From the start of treatment until 5 years post treatment
From the start of treatment until 5 years post treatment
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
Lasso di tempo: Baseline and then 4 and 8 weeks post treatment
The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
Baseline and then 4 and 8 weeks post treatment
Progression Free Survival
Lasso di tempo: from the start of treatment until the time of disease progression, up to 5 years
Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.
from the start of treatment until the time of disease progression, up to 5 years

Collaboratori e investigatori

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

Sponsor

Massachusetts General Hospital

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Shannon M MacDonald, M.D., Massachusetts General Hospital

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.

Pubblicazioni generali

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

1 giugno 2011

Completamento primario (Effettivo)

1 aprile 2017

Completamento dello studio (Anticipato)

1 gennaio 2022

Date di iscrizione allo studio

Primo inviato

20 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

20 aprile 2011

Primo Inserito (Stima)

22 aprile 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 gennaio 2021

Ultimo verificato

1 gennaio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 10-205

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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