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ISRCTN
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ISRCTN21474421
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ClinicalTrials.gov identifier
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Public title
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A Randomised Controlled Trial: Investigation of Radiotherapy Dose Inhomogeneity and Cosmetic Outcome in Patients with Early Breast Cancer
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Scientific title
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Acronym
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Cambridge IMRT
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Serial number at source
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N/A
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Study hypothesis
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Does correction of dose homogeneity improve the cosmetic outcome following radiotherapy in patients with early breast cancer?
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Ethics approval
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Approved by the Cambridge Reseach Ethics Committee on 04/02/03, reference number 03/017
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Study design
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Interventional, phase III, randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast Cancer
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2003
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Anticipated end date
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31/03/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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375
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Interventions
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Patients are randomised to receive Intensity Modulated Radiation therapy (IMRT).
Control group will receive standard 2-dimensional radiation therapy.
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Primary outcome measure(s)
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Breast shrinkage following radiotherapy
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Secondary outcome measure(s)
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1. Acute skin reactions
2. Clinical assessment of late cosmetic effect
3. Patient’s quality of life
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Sources of funding
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Breast Cancer Campaign (London), grant reference number 2001:263 (UK)
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Trial website
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Publications
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2009 baseline characteristics and dosimetry results in http://www.ncbi.nlm.nih.gov/pubmed/19375808
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Contact name
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Dr
Charlotte
Coles
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Address
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Oncology Centre
Box 193
Addenbrooke's Hospital
Hills road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Sponsor
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Cambridge University Hospitals NHS Foundation Trust (UK)
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Address
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Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Date applied
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10/01/2006
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Last edited
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16/02/2010
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Date ISRCTN assigned
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17/02/2006
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