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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation control arm | Active Comparator | Patients who will receive 40 Gy in 15 fractions to the entire breast or chest wall over three weeks and have had breast conservation surgery (BCS) or oncoplastic breast surgery(OBS) will receive an additional boost to the tumour site if and will receive sequential dose 12GY\4 fractions or SIB 8GY 15 fractions. The supraclavicular fossa will be treated in patients with node-positive disease or those who had received neoadjuvant chemotherapy . The IMLN will be irradiated in N2and N3 at first presentation. |
|
| . Ultrahypofractionation experimental arm | Experimental | Patients who will receive 26 Gy in 5 fractions to the entire breast and or chest wall for one week only. The volume of this arm will be the same as the volume of the control arm as regard axillary nodes, supraclavicular and IMLN. Patients who have had breast conservation or oncoplastic breast surgery(OBS) will be given a boost. If a boost is given, SIB of 6 Gy in 5 fractions will be used (or a sequential boost of 12GY\4 fractions). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation Radiotherapy. | Radiation | Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy. | 3 months |
| Chronic toxicity | Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment. | 6 months post treatment up to 2 years |
| Local recurrence | Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy. | Up to 2 years |
| Patient compliance | Compliance to treatment (number of interrupted days of radiotherapy. | From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival (Number of the surviving patients for 2 years in each arm of the study) | From time of diagnosis up to 2 years post radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
female adult patients with breast
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nahla M Elmahdy, assistant lecturer | Contact | 01026886840 | nahla.youssif@med.sohag.edu.eg | |
| Mohamed S gaber, professor | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University Hospital | Recruiting | Sohag | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 32221669 | Background | Gany F, Ayash C, Raad N, Wu M, Roberts-Eversley N, Mahmoud H, Fouad Y, Fahmy Y, Asar H, Salama A, El-Shinawi M. Financial and food security challenges of Egyptian women undergoing breast cancer treatment. Support Care Cancer. 2020 Dec;28(12):5787-5794. doi: 10.1007/s00520-020-05426-9. Epub 2020 Mar 27. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 10, 2023 | |
| Reset | May 31, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 10, 2023 | May 31, 2024 |
| 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 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D013812 | Therapeutics |
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|
| Ultra-hypofractionation radiotherapy | Radiation | Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week. |
|
|
| 31040712 | Background | Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019. |
| 29516087 | Background | Stapleton SM, Oseni TO, Bababekov YJ, Hung YC, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. 2018 Jun 1;153(6):594-595. doi: 10.1001/jamasurg.2018.0035. |
| D017437 |
| Skin and Connective Tissue Diseases |