One Week Adjuvant Radiotherapy for Breast Cancer

Not Applicable

• Conditions: Breast Carcinoma
• Interventions: Radiation: Hypofractionation Radiotherapy.; Radiation: Ultra-hypofractionation radiotherapy

• 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

Arm && Interventions

Group	Intervention	Description
Hypofractionation control arm	Hypofractionation Radiotherapy.	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	Ultra-hypofractionation radiotherapy	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).

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