Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

Breast Cancer Clinical Trial

— HYPOPRONE  

Official title:

Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316328
• Other study ID #: IFO-84/10
• Status: Completed
• Phase: N/A
• First received: March 15, 2011
• Last updated: March 15, 2011
• Start date: May 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The single shot partial breast irradiation (SSPBI) trial was designed as a prospective Phase II "single-arm study". The use of a single dose tumor bed is expected to be very effective in terms of tumor control, but it could increase the incidence of radiation induced erythema. Therefore, the investigators assumed that a decreased DNA repair capability, as well as a reduced detoxification of the damage caused by oxidative stress could explain the increased acute toxicity, i.e. a higher incidence of erythema after a single dose. For this reason the investigators decided to investigate SNPs of genes involved in antioxidant and DNA damage repair pathways such as GST, XRCC1, XRCC3 and RAD51.

The investigators assumed an erythema rate of 20% and 54% in patient groups at low and high risk, respectively, (groups were identified based on the absence/presence of the above polymorphisms alone or in combination), thus the minimum sample size was 56 patients with α=0.05, 2-tailed test and a power of the study of 80%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 48 years old with a life expectancy of at least 5 years

• Post-menopausal status

• Histologically proven, non lobular, adenocarcinoma of the breast

• Primary tumours = 3 cm

• Negative surgical margins (= 2 mm)

• Negative sentinel nodes or < 4 positive axillary nodes

• No extra-capsular extension

• No previous radiotherapy

Exclusion Criteria:

• multicentric disease

• extended intraductal component (EIC > 25%)

• Paget's disease

• lobular adenocarcinoma

• distant metastases All the above criteria allow to identify patients at low risk of local recurrence.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Italy	Regina Elena NCI	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy,