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

NCT01316328 | Completed

• 1 other identifier: IFO-84/10
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

toxicity after single shot partial breast irradiation (SSPBI)

Study Arms (1)

BC patients after SSPBI

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

Eligibility Criteria

• Age: 48 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

Regina Elena NCI

Rome, Rome, 00144, Italy

Location

Related Publications (3)

• 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.

  PMID: 22272830 DERIVED

• 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.

  PMID: 22079051 DERIVED

• 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.

  PMID: 21749698 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2011
• First Posted: March 16, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 16, 2011

Record last verified: 2010-12

Locations

IT (1)