Breast Cancer Clinical Trial
— IpomammellaOfficial title:
Toxicity and Outcome of Whole Breast Hypofractionated Radiotherapy Without Boost: Results of a Homogeneous Single Institution Experience
Verified date | June 2023 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a homogeneous, single institution, observational, non-interventional, prospective study of 500 patients who will be treated according to the standard protocol of adjuvant hypofractionated radiotherapy after breast conserving surgery, at a total dose of 40 Gy/ 15 fr (5 fr/ week, 3 consecutive weeks). In addition to the regular follow up, the patients will respond to the quality-of-life questionnaires (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC), general, QLQ- C30, and specific for breast (BR), QLQ- BR23, at the first visit, at the end of radiotherapy and at the subsequent follow-up visits from 6 months up to 5 and a half years, to evaluate the quality of life during and after the treatment. The study also has a retrospective arm of approximately 1300 patients, treated from January 2009, for whom disease control and toxicity will be evaluated.
Status | Active, not recruiting |
Enrollment | 410 |
Est. completion date | December 31, 2026 |
Est. primary completion date | November 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Breast cancer patients with TNM Classification of Malignant Tumours pathological stage T1-T2, N0-N1a (pathologically node negative - up to three positive lymph-nodes), treated with conservative surgery and whole breast hypofractionated radiotherapy without boost Exclusion Criteria: - male breast cancer patients - breast cancer patients treated with conservative surgery and partial breast irradiation, relapsed, and treated with adjuvant whole breast radiotherapy after salvage conservative surgery - breast cancer patients treated with mastectomy - patients with TNM pathologic stage N1a treated with whole breast radiotherapy and supraclavicular fossa +/- axillary radiotherapy |
Country | Name | City | State |
---|---|---|---|
Italy | San Raffaele Scientific Institute | Milan | MI |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele |
Italy,
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | aesthetic result | assessment of the effect of radiation therapy with photographs taken the day of treatment planning verification (before the first radiotherapy fraction), after 15 fractions of radiotherapy (at the end of radiation therapy), and during follow-up visits (the first 6 months after the end of radiotherapy and than at 18 months, 30 months, 42 months, 54 months and 66 months after the end of radiotherapy). | up to 66 months | |
Primary | quality of life after hypofractionated adjuvant radiotherapy | degree of general quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaires QLQ C30 | up to 66 months | |
Primary | breast specific quality of life after hypofractionated adjuvant radiotherapy | degree of specific quality of life worsening of patients treated with hypofractionated adjuvant radiotherapy after breast conserving surgery assessed with EORTC quality of life questionnaire QLQ BR23 | up to 66 months | |
Secondary | local control | percentage of patients without local relapse at five years | up to 66 months | |
Secondary | regional control | percentage of patients without regional (axillary, supraclavicular) relapse at five years | up to 66 months | |
Secondary | distant metastases free survival | percentage of patients without distant metastases at five years | up to 66 months | |
Secondary | disease free survival | percentage of patients without local and/or distant progression at five years | up to 66 months | |
Secondary | cancer specific survival | percentage of patients who have not died from breast cancer at five years | up to 66 months | |
Secondary | overall survival | percentage of patients alive at five years | up to 66 months | |
Secondary | acute toxicity | acute toxicity after hypofractionated whole breast adjuvant radiotherapy evaluated with Radiation Therapy Oncology Group (RTOG) scale at 5 years | up to 66 months | |
Secondary | late toxicity | late toxicity after hypofractionated whole breast adjuvant radiotherapy evaluated with Scoring systems of late effects of radiations on normal tissues SOMA-LENT scale at 5 years | up to 66 months |
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