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External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

12. oktober 2020 oppdatert av: Alphonse Taghian, MD, PhD, Massachusetts General Hospital

A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer

Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the "tumor bed").

The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients.

The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

After signing the consent form, the following will be assessed.

-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.

PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.

PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).

After the final dose of the study:

You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.

Studietype

Intervensjonell

Registrering (Faktiske)

54

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, Forente stater, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forente stater, 02215
        • Beth Isreal Deaconness Medical Center
      • Boston, Massachusetts, Forente stater, 02215
        • Brigham and Women's Hosptial

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography
  • Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen
  • Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery

Exclusion Criteria:

  • No distant metastasis
  • Not pregnant or breastfeeding
  • No diffuse suspicious microcalcifications
  • No prior radiation therapy to the ipsilateral or contralateral breast or thorax
  • No histologic evidence of lymphovascular invasion (LVI)
  • No histologic evidence of EIC
  • No history of cosmetic or reconstructive breast surgery
  • No psychiatric illness that would prevent the patient from giving informed consent
  • No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
  • No other currently active second malignancy other than non-melanoma skin cancers

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: Partial Breast Irradiation
Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks
Stråling: External Beam Partial-Breast Irradiation
40 Gy in ten daily fractions over two weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks
Tidsramme: 2 years

The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.

  1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.
  2. The development of clinical fat necrosis.
  3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.

The data is shown as the number of participants that experienced each of the specific toxicities.
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Local Control Rates
Tidsramme: 2 years
The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.
2 years
Distant Control Rates
Tidsramme: 2 years
The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.
2 years
Breast Cosmesis
Tidsramme: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years

Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.

  • Excellent: Little or no observable change
  • Good: Minimal but identifiable changes
  • Fair: Significant results of radiotherapy noted
  • Poor: Severe normal tissue sequelae
End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then 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

Beth Israel Deaconess Medical Center
Brigham and Women's 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

1. mai 2012

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. august 2019

Datoer for studieregistrering

Først innsendt

11. januar 2012

Først innsendt som oppfylte QC-kriteriene

18. april 2012

Først lagt ut (Anslag)

20. april 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 11-351

Plan for individuelle deltakerdata (IPD)

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