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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group (1) | Experimental | Hypofractionated radiotherapy women with T3-4 and /or 4 or more axillary nodes involvement post mastectomy. Hypofractionated radiotherapy 43,5 GY/15 fractions (f) /3w. to chest wall and supraclavicular nodal region. |
|
| group(2) | Active Comparator | Conventional fractionated radiotherapy breast cancer women with T3-4 and/ or 4 or more axillary nodes involvement post mastectomy. Conventional fractionated radiotherapy 50 Gray(GY)/25 fractions (f)/5w to chest wall and supraclavicular nodal region. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated radiotherapy | Radiation | Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse. | 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. | two years |
| Frequency of local recurrence. | Comparison between the treatment groups. | one year |
| Toxicity outcome/ side affects that may occur with breast radiation therapy. | Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency. | two years |
| Histopathologic grades of the tumor. | Comparison between the two treatment groups. | one year |
| Pathological tumour size (pT stage classification) | cT 3-4 | one year |
| Pathological node status (pN stage classification) (cN) | cN 2 (4 or more positive axillary lymph nodes. | one year |
| Frequency of distant metastasis | Compare two treatment groups regarding the frequency of distant metastasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival. | Any deaths | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nehal K Ali, M.S.C | Contact | 1002085589 | ahmedabozeid185@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut faculty of medicine , clinical oncology and nuclear medicine department | Recruiting | Asyut | 088 | Egypt |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Assignment Masking: open label
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Check none
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| Conventional fractionated radiotherapy | Radiation | 50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region |
|
| two years |
| D017437 |
| Skin and Connective Tissue Diseases |