One Week Adjuvant Radiotherapy for Breast Cancer

May 5, 2022 updated by: Nahla Mohamed Elmahdy, Sohag University

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

  • 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypofractionation control arm
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.
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.
Other Names:
  • 3 weeks radiotherapy.
Experimental: . Ultrahypofractionation experimental arm
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).
Radiation: 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.
Other Names:
  • 1 week accelerated hypo-fractionation radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicity
Time Frame: 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.
3 months
Chronic toxicity
Time Frame: 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.
6 months post treatment up to 2 years
Local recurrence
Time Frame: Up to 2 years
Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.
Up to 2 years
Patient compliance
Time Frame: 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.
From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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)
From time of diagnosis up to 2 years post radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

November 3, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21_10_18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Carcinoma

Clinical Trials on Hypofractionation Radiotherapy.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe