Breast Cancer
Conditions
Brief summary
The purpose of this study is to compare the efficacy and toxicities of hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's hypothesized that the efficacy and toxicities are similar between the two groups.
Detailed description
Eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (HF) radiotherapy of 43.5 Gray (GY) in 15 fractions within 3 weeks to the same region. During and after radiotherapy , the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
Interventions
RADIATIONHypofractionated radiotherapy
Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. .
50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region
Sponsors
Ahmed Ahm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Check none
Intervention model description
Assignment Masking: open label
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer * Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes. * Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation. * Written informed concent. * C T3-4 , or C N2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy. * No supraclavicular or internal mammary nodes metastases. * No distant metastases .Enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who did't receive neoadjuvant therapy. * Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did't need adjuvant chemotherapy.
Exclusion criteria
* Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * Previous or concurrent malignant other than non melanomatous skin cancer * Bilateral breast cancer. * Immediate or delayed ipsilateral breast cancer reconstruction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of distant metastasis | two years | Compare two treatment groups regarding the frequency of distant metastasis. |
| Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse. | two years | 60 female patients with high risk post mastectomy breast cancer will divided randomly into two equal groups One group will received hypofractionated (HF) regimen of postoperative radiotherapy, and group two will receive conventional fractionated (CF) regimen of postoperative local radiotherapy. in high risk breast cancer , comparison between the two treated groups. |
| Frequency of local recurrence. | one year | Comparison between the treatment groups. |
| Toxicity outcome/ side affects that may occur with breast radiation therapy. | two years | Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency. |
| Histopathologic grades of the tumor. | one year | Comparison between the two treatment groups. |
| Pathological tumour size (pT stage classification) | one year | cT 3-4 |
| Pathological node status (pN stage classification) (cN) | one year | cN 2 (4 or more positive axillary lymph nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival. | two years | Any deaths |
Countries
Egypt
Contacts
Primary ContactNehal K Ali, M.S.C
Outcome results
None listed