Condition category
Cancer
Date applied
10/01/2006
Date assigned
17/02/2006
Last edited
22/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Charlotte Coles

ORCID ID

Contact details

Oncology Centre
Box 193
Addenbrooke's Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Cambridge IMRT

Study hypothesis

Does correction of dose homogeneity improve the cosmetic outcome following radiotherapy in patients with early breast cancer?

Ethics approval

Approved by the Cambridge Reseach Ethics Committee on 04/02/03, reference number 03/017

Study design

Interventional, phase III, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast Cancer

Intervention

Patients are randomised to receive Intensity Modulated Radiation therapy (IMRT).
Control group will receive standard 2-dimensional radiation therapy.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Breast shrinkage following radiotherapy

Secondary outcome measures

1. Acute skin reactions
2. Clinical assessment of late cosmetic effect
3. Patient’s quality of life

Overall trial start date

01/04/2003

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18 years and above
2. Operable unilateral breast cancer (T1-3, N0-1, M0 at presentation)
3. Histological confirmation of invasive carcinoma
4. Complete macroscopic excision of tumour by breast conserving surgery
5. No history of contralateral breast cancer
6. Demonstration of off-axis dose inhomogeneities outside -5% and +7% of the prescribed dose using conventional 2-dimensional radiotherapy treatment plan
7. Patients’ consents to be part of the trial and availability for follow-up

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

375

Participant exclusion criteria

1. Patients with advance or metastatic breast cancer
2. Patients who have had a mastectomy
3. Patients with bilateral breast cancer
4. Concomitant invasive malignancy (apart from Cervical Intra-epithelial Neoplasia [CIN] III uterine cervix and basal carcinoma of the skin), if other previous malignancies, must be disease-free for five years

Recruitment start date

01/04/2003

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oncology Centre
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Breast Cancer Campaign (London), grant reference number 2001:263 (UK)

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

1. 2009 baseline characteristics and dosimetry results in http://www.ncbi.nlm.nih.gov/pubmed/19375808
2. 2012 prospective analysis study in http://www.ncbi.nlm.nih.gov/pubmed/22169268

Publication citations

  1. Baseline characteristics and dosimetry results

    Barnett GC, Wilkinson J, Moody AM, Wilson CB, Sharma R, Klager S, Hoole AC, Twyman N, Burnet NG, Coles CE, A randomised controlled trial of forward-planned radiotherapy (IMRT) for early breast cancer: baseline characteristics and dosimetry results., Radiother Oncol, 2009, 92, 1, 34-41, doi: 10.1016/j.radonc.2009.03.003.

  2. Prospective analysis study

    Barnett GC, Coles CE, Elliott RM, Baynes C, Luccarini C, Conroy D, Wilkinson JS, Tyrer J, Misra V, Platte R, Gulliford SL, Sydes MR, Hall E, Bentzen SM, Dearnaley DP, Burnet NG, Pharoah PD, Dunning AM, West CM, Independent validation of genes and polymorphisms reported to be associated with radiation toxicity: a prospective analysis study., Lancet Oncol., 2012, 13, 1, 65-77, doi: 10.1016/S1470-2045(11)70302-3.

Additional files

Editorial Notes