- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01413269
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100021
- Cancer Hospital, Chinese Academy of Medical Sciences
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Beijing
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Beijing, Beijing, Chine, 100730
- Beijing Hospital
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Shanghai
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Shanghai, Shanghai, Chine, 200032
- Zhongshan Hospital Fudan University
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Zhejiang
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Hang-zhou, Zhejiang, Chine, 310022
- Zhejiang Cancer Hospital
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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
Inclusion Criteria:
- KPS>=60
- histology confirmed invasive breast cancer
- received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
- surgical margins negative
- primary tumor ≤5cm in the largest diameter
- no internal mammary node or supraclavicular node metastases or distant metastasis
- can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
- for patients not need chemotherapy,enrollment date is required no more than 8 weeks from surgery date
- for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
- patients signed written inform consent form
Exclusion Criteria:
- ductal carcinoma in situ
- prior neoadjuvant chemotherapy
- prior breast cancer history
- bilateral breast cancer
- pregnant or during lactation
- prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
- active collagen vascular disease
- prior neoadjuvant hormone therapy
- immediate ipsilateral breast reconstruction
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: hypofractionation radiotherapy
irradiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
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one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week. |
Comparateur actif: conventional fractionation radiotherapy
irradiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
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one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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in-breast recurrence rate
Délai: 5 year
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evidence of ipsilateral breast local recurrence confirmed by histology
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5 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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regional node recurrence rate
Délai: 5 year
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ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.
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5 year
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disease-free survival
Délai: 5 year
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locoregional relapse, distant relapse, death
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5 year
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overall survival
Délai: 5 year
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any death
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5 year
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acute toxicity
Délai: 6 months
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radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
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6 months
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late complication
Délai: 3 -10 year
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breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction
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3 -10 year
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Shu-lian Wang, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Chaise d'étude: Ye-xiong Li, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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 (Réel)
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
- CH-BC-013
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