Condition category
Cancer
Date applied
10/04/2007
Date assigned
13/04/2007
Last edited
07/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Vinh-Hung

ORCID ID

Contact details

Oncologisch Centrum
UZ Brussel
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 6041
conrvhgv@uzbrussel.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2007/009

Study information

Scientific title

Acronym

TomoBreast

Study hypothesis

To test that short course adjuvant radiotherapy with the Tomotherapy system will substantially reduce the incidence of pulmonary and cardiac toxicities, as compared with conventional radiotherapy.

Ethics approval

Approved by the Medical Ethics Committee of the UZ Brussel on the 29th March 2007 (ref: 2007/009; B.U.N. ref: B14320071552).

Study design

Randomised, controlled, single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Patients eligible for adjuvant post-surgery radiotherapy are randomised between treatment by conventional radiotherapy (control arm) and treatment with Tomotherapy (experimental arm).

Arm I (control, conventional radiotherapy):
Radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure.
Dose-fractionation: 50 Gy in 25 fractions over five weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over two weeks if breast conserving surgery and aged less than or equal to 70 years.

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pulmonary and cardiac toxicities: this will be assessed by respiratory and heart function tests at one to three months after completion of radiotherapy then yearly for three years.

Secondary outcome measures

Local-regional recurrences: this will be assessed at one month after completion of radiotherapy then every three months for three years, then every six months for three years, then yearly thereafter.

Overall trial start date

01/05/2007

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Informed consent
2. Women
3. Age 18 years or older
4. Histologically proven invasive breast carcinoma, stage I or II (T1-3N0 or T1-2N1M0, TNM 6th edition)
5. Surgery with clear margins
6. Pre-operative medical imaging (at least Computed Tomography [CT], Magnetic Resonance Imaging [MRI], and/or Positron Emission Tomography [PET]-scan)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

118

Participant exclusion criteria

1. Patients who do not match inclusion criteria
2. Prior breast or thoracic radiotherapy
3. Pregnancy or lactation
4. Fertile patients without effective contraception
5. Psychiatric or addictive disorders

Recruitment start date

01/05/2007

Recruitment end date

30/04/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Oncologisch Centrum
Brussels
1090
Belgium

Sponsor information

Organisation

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)

Sponsor details

c/o Dr Vincent Vinh-Hung
Radiotherapy-Oncology Department
Laarbeeklaan 101
Brussels
1090
Belgium
+32 (0)2 477 6041
conrvhgv@uzbrussel.be

Sponsor type

Hospital/treatment centre

Website

http://www.uzbrussel.be

Funders

Funder type

Charity

Funder name

Foundation Against Cancer (Stichting tegen Kanker) (Belgium)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22591589

Publication citations

  1. Results

    Adriaenssens N, De Ridder M, Lievens P, Van Parijs H, Vanhoeij M, Miedema G, Voordeckers M, Versmessen H, Storme G, Lamote J, Pauwels S, Vinh-Hung V, Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy., World J Surg Oncol, 2012, 10, 86, doi: 10.1186/1477-7819-10-86.

Additional files

Editorial Notes