IBCC Oncologia
São Paulo, 03102-002, Brazil
Location status: Recruiting
Location contact
Alayne D Yamada, PhD
CONTACT
Eduardo Barbieri
CONTACT
Eduardo Barbieri
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04669873
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.
There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
Interested in participating?
Request Info50 year–90 year
Female
Interventional
Not applicable
São Paulo, 03102-002, Brazil
Location status: Recruiting
Alayne D Yamada, PhD
CONTACT
Eduardo Barbieri
CONTACT
Eduardo Barbieri
PRINCIPAL_INVESTIGATOR
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
Time frame: 5 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
Time frame: 5 years
Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.
Time frame: 5 years
Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
Time frame: 5 years
Overall survival time, defined as number of days from randomization until death or end of follow-up.
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts. The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). Scores are interpreted according to the guidelines of the Scoring Manual. The higher the number of points, the better the quality of life. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS). Scores are interpreted according to the guidelines of the Scoring Manual. The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment. The total score ranges from 0 to 30. A higher score means a higher level of body image disturbance.
Time frame: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS). Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
Time frame: 5 years
To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
Time frame: 5 years
To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.
Time frame: 5 years
To evaluate acute toxicity rate. The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.
Contact information is provided by the study sponsor or research team.
Alayne D Yamada, PhD
CONTACT
Eduardo Barbieri
CONTACT
Instituto Brasileiro de Controle do Cancer
Other
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
Acronym: LAPIDARY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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