NCT00459628

Brief Summary

Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
6.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

April 11, 2007

Last Update Submit

May 12, 2017

Conditions

Breast Neoplasms

Keywords

early breast cancerpost-operative radiation treatment

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pulmonary function and heart function tests

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

    From end of treatment up to 3 years after treatment

Secondary Outcomes (1)

  • Local-regional recurrences.

    From end of treatment up to 15 years after treatment

Study Arms (2)

Conventional radiotherapy

ACTIVE COMPARATOR

Conventional Long schedule Radiotherapy Arm

Radiation: Conventional radiotherapy

Tomotherapy

EXPERIMENTAL

Short course schedule by tomotherapy

Radiation: Tomotherapy

Interventions

Conventional radiotherapyRADIATION

Radiation treatment delivered by conventional linear accelerator using matching fields

Also known as: Arm I, Long schedule
Conventional radiotherapy
TomotherapyRADIATION

CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system

Also known as: Arm II, Short schedule, Helical Tomotherapy
Tomotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Prior breast or thoracic radiotherapy
  • Pregnancy or lactation
  • Fertile patients without effective contraception
  • Psychiatric or addictive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncologisch Centrum, UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (10)

  • Voordeckers M, Van de Steene J, Vinh-Hung V, Storme G. Adjuvant radiotherapy after mastectomy for pT1-pT2 node negative (pN0) breast cancer: is it worth the effort? Radiother Oncol. 2003 Sep;68(3):227-31. doi: 10.1016/s0167-8140(03)00234-2.

    PMID: 13129629BACKGROUND

  • Voordeckers M, Vinh-Hung V, Van de Steene J, Lamote J, Storme G. The lymph node ratio as prognostic factor in node-positive breast cancer. Radiother Oncol. 2004 Mar;70(3):225-30. doi: 10.1016/j.radonc.2003.10.015.

    PMID: 15064006BACKGROUND

  • Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.

    PMID: 12165639BACKGROUND

  • Versmessen H, Vinh-Hung V, Van Parijs H, Miedema G, Voordeckers M, Adriaenssens N, Storme G, De Ridder M. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy. BMC Cancer. 2012 Oct 25;12:495. doi: 10.1186/1471-2407-12-495.

    PMID: 23098579RESULT

  • Van Parijs H, Miedema G, Vinh-Hung V, Verbanck S, Adriaenssens N, Kerkhove D, Reynders T, Schuermans D, Leysen K, Hanon S, Van Camp G, Vincken W, Storme G, Verellen D, De Ridder M. Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial. Radiat Oncol. 2012 Jun 1;7:80. doi: 10.1186/1748-717X-7-80.

    PMID: 22656865RESULT

  • 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 May 16;10:86. doi: 10.1186/1477-7819-10-86.

    PMID: 22591589RESULT

  • Adriaenssens N, Vinh-Hung V, Miedema G, Versmessen H, Lamote J, Vanhoeij M, Lievens P, van Parijs H, Storme G, Voordeckers M, De Ridder M. Early contralateral shoulder-arm morbidity in breast cancer patients enrolled in a randomized trial of post-surgery radiation therapy. Breast Cancer (Auckl). 2012;6:79-93. doi: 10.4137/BCBCR.S9362. Epub 2012 Jul 30.

    PMID: 22904635RESULT

  • Verbanck S, Hanon S, Schuermans D, Van Parijs H, Vinh-Hung V, Miedema G, Verellen D, Storme G, Vanhoeij M, Lamote J, De Ridder M, Vincken W. Small airways function in breast cancer patients before and after radiotherapy. Breast Cancer Res Treat. 2012 Oct;135(3):857-65. doi: 10.1007/s10549-012-2201-7. Epub 2012 Aug 22.

    PMID: 22910929RESULT

  • Van Parijs H, Cecilia-Joseph E, Gorobets O, Storme G, Adriaenssens N, Heyndrickx B, Verschraegen C, Nguyen NP, De Ridder M, Vinh-Hung V. Lung-heart toxicity in a randomized clinical trial of hypofractionated image guided radiation therapy for breast cancer. Front Oncol. 2023 Nov 20;13:1211544. doi: 10.3389/fonc.2023.1211544. eCollection 2023.

    PMID: 38053657DERIVED

  • Van Parijs H, Vinh-Hung V, Fontaine C, Storme G, Verschraegen C, Nguyen DM, Adriaenssens N, Nguyen NP, Gorobets O, De Ridder M. Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer. BMC Cancer. 2021 Nov 4;21(1):1177. doi: 10.1186/s12885-021-08916-z.

    PMID: 34736429DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Mark De Ridder, MD, PhD

    Radiotherapy Department, Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

  • Vincent Vinh-Hung, MD, PhD

    Radiotherapy-Oncology, Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

May 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2017

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations

BE(1)