One Week Adjuvant Radiotherapy for Breast Cancer

Not Applicable

• Conditions: Breast Carcinoma

• Registration Number: NCT05150535
• Lead Sponsor: Sohag University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acute toxicity	3 months	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.
Chronic toxicity	6 months post treatment up to 2 years	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.
Local recurrence	Up to 2 years	Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.
Patient compliance	From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm	Compliance to treatment (number of interrupted days of radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From time of diagnosis up to 2 years post radiotherapy	Overall survival (Number of the surviving patients for 2 years in each arm of the study)

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt