- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01340495
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
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 Radiation
Radiation therapy with proton beam
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
Tidsramme: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
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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.
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From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Number of Participants With Acute Skin Toxicities
Tidsramme: 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
Tidsramme: 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).
|
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
Tidsramme: 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
Tidsramme: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
|
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Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
Tidsramme: 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
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The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
Tidsramme: From the start of treatment until 5 years post treatment
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From the start of treatment until 5 years post treatment
|
|
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
Tidsramme: 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.
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Baseline and then 4 and 8 weeks post treatment
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Progression Free Survival
Tidsramme: from the start of treatment until the time of disease progression, up to 5 years
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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.
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from the start of treatment until the time of disease progression, up to 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Shannon M MacDonald, M.D., Massachusetts General Hospital
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10-205
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