| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN21474421 |
| Date ISRCTN assigned | 17/02/2006 |
| Local reference number(s) | N/A |
| Public title | A Randomised Controlled Trial: Investigation of Radiotherapy Dose Inhomogeneity and Cosmetic Outcome in Patients with Early Breast Cancer |
| Scientific title |
|
| Acronym | Cambridge IMRT |
| Disease/condition/study domain | Breast Cancer |
| Study hypothesis | Does correction of dose homogeneity improve the cosmetic outcome following radiotherapy in patients with early breast cancer? |
| Design/methodology | Interventional, phase III, randomised controlled trial |
| Research ethics review | Approved by the Cambridge Reseach Ethics Committee on 04/02/03, reference number 03/017 |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 31/03/2006 |
| Status of trial | Completed |
| Target number of participants | 375 |
| Interventions | Patients are randomised to receive Intensity Modulated Radiation therapy (IMRT).
Control group will receive standard 2-dimensional radiation therapy. |
| Primary outcome measure(s) | Breast shrinkage following radiotherapy |
| Secondary outcome measure(s) | 1. Acute skin reactions
2. Clinical assessment of late cosmetic effect
3. Patient’s quality of life |
| Sources of funding | Breast Cancer Campaign (London),
grant reference number 2001:263 |
| Sponsor name | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Sponsor details | Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills road
Cambridge
United Kingdom
CB2 2QQ |
| Contact name | Dr Charlotte Coles |
| Contact details | Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
United Kingdom
CB2 2QQ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN21474421 |
| Date last extracted from ISRCTN register | 17/04/2008 |
