- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00005983
S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer
Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy.
- Compare local regional control in patients treated with these regimens.
- Assess the potential toxic effects of radiotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Hamilton, Ontario, Kanada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically confirmed stage II adenocarcinoma of the breast (T1-2, N1, M0)
- Primary tumor no greater than 5 cm
- At least 1 but no more than 3 positive axillary lymph nodes
- Nodes cannot be positive solely by cytokeratin staining
- No apocrine, adenocystic, or squamous cell carcinomas or sarcomas of the breast
- No bilateral breast cancer
- No active local regional disease
Must have undergone a modified radical mastectomy with a level I and II with or without a level III axillary dissection (at least 10 nodes examined) within the past 8 months
- Surgical margins negative for invasive and noninvasive ductal carcinoma
- No gross extracapsular disease or residual disease in the axilla
- Microscopic extracapsular extension allowed
- No mastectomy after local failure following lumpectomy
- Must have received adjuvant chemotherapy and/or hormonal therapy after mastectomy
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Sex:
- Female
Menopausal status:
- Pre- or post-menopausal
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No serious medical or psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior trastuzumab (Herceptin)
Chemotherapy:
- See Disease Characteristics
- No more than 6 weeks since prior adjuvant chemotherapy
- No other prior chemotherapy
- Concurrent adjuvant chemotherapy allowed
Endocrine therapy:
- See Disease Characteristics
- Concurrent adjuvant hormonal therapy allowed
Radiotherapy:
- No prior chest wall or nodal radiotherapy
Surgery:
- See Disease Characteristics
- Breast reconstruction allowed
Other:
- Concurrent registration on another adjuvant chemotherapy or hormonal therapy study is allowed
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: surgery
surgery followed by observation
|
Operation
|
Experimental: surgery followed by RT
Surgery followed by radiation therapy
|
Operation
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Timothy J. Whelan, MD, Margaret and Charles Juravinski Cancer Centre
- Studienstuhl: Lori J. Pierce, MD, University of Michigan Rogel Cancer Center
- Studienstuhl: Stephen B. Edge, MD, Roswell Park Cancer Institute
- Studienstuhl: Eric A. Strom, MD, FACR, M.D. Anderson Cancer Center
- Studienstuhl: Lawrence J. Solin, MD, FACR, Abramson Cancer Center of the University of Pennsylvania
- Studienstuhl: Lawrence B. Marks, MD, Duke University
- Studienstuhl: Melvin Deutsch, MD, UPMC Cancer Center at UPMC Presbyterian
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CDR0000067971
- U10CA032102 (US NIH Stipendium/Vertrag)
- S9927 (Andere Kennung: NSABP)
- CAN-NCIC-MA25 (Andere Kennung: NCIC-CTG)
- CLB-49910 (Andere Kennung: CALGB)
- RTOG-9915 (Andere Kennung: RTOG)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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