One Week Adjuvant Radiotherapy for Breast Cancer

Breast Carcinoma Clinical Trial

Official title:

A Prospective Study of One Week Accelerated Hypo-fractionation Adjuvant Radiotherapy in High-risk Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150535
• Other study ID #: Soh-Med-21_10_18
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2022
• Source: Sohag University
• Contact: Nahla M Elmahdy, assistant lecturer
• Phone: 01026886840
• Email: nahla.youssif[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth.

• Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer.

• More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.

• Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.

• All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy

Exclusion Criteria:

• Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.

• Postoperative positive margin.

• Carcinomas in situ.

• Mesenchymal breast lesions.

• Locoregional recurrent breast cancer.

• Synchronous bilateral breast cancer.

• very early breast cancer (T1-2N0M0,T1N1M0).

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Radiation:
• Hypofractionation Radiotherapy.
Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.
• Ultra-hypofractionation radiotherapy
Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Local recurrence	Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.	Up to 2 years
Primary	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
Secondary	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