One Week Adjuvant Radiotherapy for Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-10-01

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Hypofractionation Radiotherapy.

Intervention Type RADIATION

Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.

. 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).

Group Type EXPERIMENTAL

Ultra-hypofractionation radiotherapy

Intervention Type RADIATION

Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.

Interventions

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Hypofractionation Radiotherapy.

Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.

Intervention Type 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.

Intervention Type RADIATION

Other Intervention Names

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3 weeks radiotherapy. 1 week accelerated hypo-fractionation radiotherapy

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No