Radiation Dose Intensity Study in Breast Cancer in Young Women

Sponsor
The Netherlands Cancer Institute
Study ID
NCT00212121
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • high dose boost — RADIATION
    high dose boost
  • boost — PROCEDURE
    low dose versus high dose

Study Details

hypothesis: 10 Gy additional boost to the tumor bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.

Key Dates

Start date
Jul 31, 2004
Status verified
Jan 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
2,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    low dose boost (16 Gy)
  • Experimental: 2
    high boost (26 Gy)

Primary Outcome Measure

Local control at 10 yr [ Time Frame: at every follow up visit (< 2 months after last radiation treatment and thereafter yearly ]

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