- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00818051
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
- Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.
After completion of study treatment, patients are followed annually for 10 years.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
England
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Sutton, England, Storbritannia, SM2 5PT
- Rekruttering
- Royal Marsden - Surrey
-
Ta kontakt med:
- John R. Yarnold, MD, FRCR
- Telefonnummer: 44-20-8661-3388
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
- Resectable, unilateral disease
- T1-3, N0-1, M0 disease
- Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
- Age 18-49 years
- Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
- Tumor of any size treated by primary medical therapy
- Grade III disease
- Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
- Lymphovascular invasion
- Axillary node positive
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mastectomy
- No concurrent chemotherapy except primary or sequential chemotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Arm I (control)
Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
|
Given as 48, 53, or 56 Gy
|
Eksperimentell: Arm II
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
|
Given as 48, 53, or 56 Gy
|
Eksperimentell: Arm III
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
|
Given as 48, 53, or 56 Gy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Palpable induration inside the boost volume of the irradiated breast
|
Sekundære resultatmål
Resultatmål |
---|
Total overlevelse
|
Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
|
Local tumor control
|
Location of tumor relapse in breast
|
Contralateral primary tumors
|
Regional and distant metastases
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000629770
- ICR-IMPORT-HIGH
- ICR-CTSU/2007/10013
- ISRCTN47437448
- EU-20897
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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