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

This study has been completed.
Sponsor:
Information provided by:
Regina Elena Cancer Institute
ClinicalTrials.gov Identifier:
NCT01316328
First received: March 15, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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%.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regina Elena Cancer Institute:

Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
BC patients after SSPBI
breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery

  Eligibility

Ages Eligible for Study:   48 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316328

Locations
Italy
Regina Elena NCI
Rome, Italy, 00144
Sponsors and Collaborators
Regina Elena Cancer Institute
  More Information

No publications provided by Regina Elena Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01316328     History of Changes
Other Study ID Numbers: IFO-84/10
Study First Received: March 15, 2011
Last Updated: March 15, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Regina Elena Cancer Institute:
toxicity after single shot partial breast irradiation (SSPBI)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013