Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: radiotherapy

• Registration Number: NCT01413269
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Primary Completion: 2015-09
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 720

Inclusion Criteria

1. KPS>=60
2. histology confirmed invasive breast cancer
3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
4. surgical margins negative
5. primary tumor ≤5cm in the largest diameter
6. no internal mammary node or supraclavicular node metastases or distant metastasis
7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
10. patients signed written inform consent form

Exclusion Criteria

1. ductal carcinoma in situ
2. prior neoadjuvant chemotherapy
3. prior breast cancer history
4. bilateral breast cancer
5. pregnant or during lactation
6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
7. active collagen vascular disease
8. prior neoadjuvant hormone therapy
9. immediate ipsilateral breast reconstruction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional fractionation radiotherapy	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.
hypofractionation radiotherapy	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.

Primary Outcome Measures

Name	Time	Method
in-breast recurrence rate	5 year	evidence of ipsilateral breast local recurrence confirmed by histology

Secondary Outcome Measures

Name	Time	Method
acute toxicity	6 months	radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
regional node recurrence rate	5 year	ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.
disease-free survival	5 year	locoregional relapse, distant relapse, death
overall survival	5 year	any death
late complication	3 -10 year	breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction

Trial Locations

Locations (4)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Beijing hospital; 🇨🇳 Beijing, Beijing, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hang-zhou, Zhejiang, China