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Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer

Prior to surgery: histological confirmation; medical imaging.

Localizing markers are placed in case of breast conserving surgery.

After surgery, patients are randomized to one of two treatment arms:

- Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of
nodal involvement, according to our hospital's standard procedure (Voordeckers M et al,
Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions
over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if
breast conserving surgery (verify marker/clip localization) and age <= 70 years.

- Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall,
nodal areas) delimited according to pre-operative imaging and pathological description.
Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15
fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast
conserving surgery.

Physics quality control is integrated during treatment in both arms.

Radiotherapy begins within 6 weeks after the last breast surgery. Concurrent or sequential
adjuvant systemic treatments are allowed. In case of sequential adjuvant treatment with
chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant

Quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to
radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.

Inclusion Criteria:

- Informed consent

- Histologically proven breast carcinoma

- Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition)

- Surgery with clear margins

- Pre-operative medical imaging (at least CT, MRI, and/or PET-scan)

Exclusion Criteria:

- Prior breast or thoracic radiotherapy

- Pregnancy or lactation

- Fertile patients without effective contraception

- Psychiatric or addictive disorders

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from baseline in pulmonary function and heart function tests

Outcome Description:

Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment

Outcome Time Frame:

From end of treatment up to 3 years after treatment

Safety Issue:


Principal Investigator

Mark De Ridder, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Radiotherapy Department, Universitair Ziekenhuis Brussel


Belgium: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

December 2014

Related Keywords:

  • Breast Neoplasms
  • early breast cancer
  • post-operative radiation treatment
  • Breast Neoplasms
  • Neoplasms