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

Breast Cancer Clinical Trial

Official title:

Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413269
• Other study ID #: CH-BC-013
• Status: Completed
• Phase: Phase 3
• Start date: June 2010
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: September 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• radiotherapy
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.

Locations

Country	Name	City	State
China	Beijing hospital	Beijing	Beijing
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	Zhejiang Cancer Hospital	Hang-zhou	Zhejiang
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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