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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01413269

CH-BC-013

Details and patient eligibility

About

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.

Enrollment: 720 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

720 participants in 2 patient groups

hypofractionation radiotherapy

Experimental group

Description:

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.

Treatment:

Radiation: radiotherapy

conventional fractionation radiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: radiotherapy