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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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England
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Sutton, England, Royaume-Uni, SM2 5PT
- Recrutement
- Royal Marsden - Surrey
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Contact:
- John R. Yarnold, MD, FRCR
- Numéro de téléphone: 44-20-8661-3388
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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
|
|
Expérimental: Arm II
Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
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Given as 48, 53, or 56 Gy
|
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
|---|
|
Palpable induration inside the boost volume of the irradiated breast
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Mesures de résultats secondaires
Mesure des résultats |
|---|
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La survie globale
|
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Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
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Local tumor control
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Location of tumor relapse in breast
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Contralateral primary tumors
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Regional and distant metastases
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000629770
- ICR-IMPORT-HIGH
- ICR-CTSU/2007/10013
- ISRCTN47437448
- EU-20897
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