Prospective randomised clinical trial testing 5.7 Gy and 6.0 Gy fractions of whole breast radiotherapy in terms of late normal tissue responses and tumour control

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62488883

Enrollment

900

Registered

2005-01-10

Start date

2004-10-01

Completion date

Unknown

Last updated

2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early breast cancer Cancer Breast

Interventions

Control arm: 50 Gy in 25 fractions over 5 weeks Test arm 1: 30 Gy in 5 fractions over 5 weeks Test arm 2: 28.5 Gy in 5 fractions over 5 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women over the age of 49 years with invasive breast cancer who have had breast preserving surgery 2. Tumour size less than 3 cm with complete resection and node negative

Exclusion criteria

Exclusion criteria: 1. Age less than 50 years 2. Mastectomy 3. Lymphatic radiotherapy or radiotherapy boost 4. Neoadjuvant or adjuvant cytotoxic therapy

Design outcomes

Primary

Measure	Time frame
Change in photographic breast appearance.	—

Secondary

Measure	Time frame
Tumour recurrence in the breast.	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026