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

NCT ID: NCT01316328

Last Updated: 2011-03-16

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-12-31

Brief 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%.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BC patients after SSPBI

breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Locations

Regina Elena NCI

Rome, Rome, Italy

Countries

Italy

References

Falvo E, Strigari L, Citro G, Giordano C, Boboc G, Fabretti F, Bruzzaniti V, Bellesi L, Muti P, Blandino G, Pinnaro P. SNPs in DNA repair or oxidative stress genes and late subcutaneous fibrosis in patients following single shot partial breast irradiation. J Exp Clin Cancer Res. 2012 Jan 24;31(1):7. doi: 10.1186/1756-9966-31-7.

Reference Type: DERIVED

PMID: 22272830 (View on PubMed)

Pinnaro P, Arcangeli S, Giordano C, Arcangeli G, Impiombato FA, Pinzi V, Iaccarino G, Soriani A, Landoni V, Strigari L. Toxicity and cosmesis outcomes after single fraction partial breast irradiation in early stage breast cancer. Radiat Oncol. 2011 Nov 11;6:155. doi: 10.1186/1748-717X-6-155.

Reference Type: DERIVED

PMID: 22079051 (View on PubMed)

Falvo E, Strigari L, Citro G, Giordano C, Arcangeli S, Soriani A, D'Alessio D, Muti P, Blandino G, Sperduti I, Pinnaro P. Dose and polymorphic genes xrcc1, xrcc3, gst play a role in the risk of articledeveloping erythema in breast cancer patients following single shot partial breast irradiation after conservative surgery. BMC Cancer. 2011 Jul 12;11:291. doi: 10.1186/1471-2407-11-291.

Reference Type: DERIVED

PMID: 21749698 (View on PubMed)

Other Identifiers

IFO-84/10

Identifier Type: -

Identifier Source: org_study_id