One Week Adjuvant Radiotherapy for Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Radiation: Hypofractionation Radiotherapy.
* Radiation: Ultra-hypofractionation radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypofractionation control arm<br>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.<br>* Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.<br>* Other names: 3 weeks radiotherapy.;|
| Experimental: . Ultrahypofractionation experimental arm<br>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<br>* Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.<br>* Other names: 1 week accelerated hypo-fractionation radiotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |