Determination of Predictive Genetic Markers of Toxicity After Hypofractionated Radiotherapy in Breast Cancer Patients Post-Conservative Surgery (HYPOPRONE)
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| ClinicalTrials.gov Identifier: NCT01316328 |
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Recruitment Status :
Completed
First Posted : March 16, 2011
Last Update Posted : March 16, 2011
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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 or disease |
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| Breast Cancer |
| Study Type : | Observational |
| 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 |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Group/Cohort |
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BC patients after SSPBI
breast cancer (BC) patients following single shot partial breast irradiation (SSPBI) after breast conservative surgery
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| Ages Eligible for Study: | 48 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age ≥ 48 years old with a life expectancy of at least 5 years
- Post-menopausal status
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316328
| Italy | |
| Regina Elena NCI | |
| Rome, Italy, 00144 | |
| ClinicalTrials.gov Identifier: | NCT01316328 |
| Other Study ID Numbers: |
IFO-84/10 |
| First Posted: | March 16, 2011 Key Record Dates |
| Last Update Posted: | March 16, 2011 |
| Last Verified: | December 2010 |
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toxicity after single shot partial breast irradiation (SSPBI) |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |