Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast

Summary

Hypotheses:

1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast).
2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm.
3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization.

Overall Objectives:

1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy.
2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.

Conditions

• Carcinoma, Ductal, Breast

Interventions

RADIATION

Standard WB fractionation

A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

RADIATION

Shorter WB fractionation

A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight).

RADIATION

Standard WB fractionation+Boost

Whole Breast: A total dose of 50 Gy in 25 fractions in 2-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 5 fractions in 2-Gy daily fractions, 5 fractions per week.

RADIATION

Shorter WB fractionation + Boost

Whole breast: A total dose of 42.5 Gy in 16 fractions in 2.656-Gy daily fractions, 5 fractions per week (at least 9 fractions per fortnight). Tumour bed: A total dose of 10 Gy in 4 fractions in 2.5-Gy daily fractions, 4 fractions per week.

Sponsors & Collaborators

• Breast International Group

  collaborator OTHER

• NCIC Clinical Trials Group

  collaborator NETWORK

• Cancer Trials Ireland

  collaborator NETWORK

• Borstkanker Onderzoek Groep

  collaborator NETWORK

• ETOP IBCSG Partners Foundation

  collaborator NETWORK

• Scottish Cancer Trials Breast Group

  collaborator UNKNOWN

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• Trans Tasman Radiation Oncology Group

  lead OTHER

Principal Investigators

• Boon Chua · Prince of Wales Hospital Randwick

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2024-06-30

Completion

2024-06-30

Countries

• Australia
• Belgium
• Canada
• France
• Ireland
• Italy
• Netherlands
• New Zealand
• Singapore
• Switzerland
• United Kingdom

Study Locations