One Week Adjuvant Radiotherapy for Breast Cancer

Sohag University

Status: Unknown

Conditions: Breast Carcinoma

Treatments: Radiation: Hypofractionation Radiotherapy.; Radiation: Ultra-hypofractionation radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05150535

Soh-Med-21_10_18

Details and patient eligibility

About

• 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Hypofractionation control arm

Active Comparator group

Description:

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.

Treatment:

Radiation: Hypofractionation Radiotherapy.

. Ultrahypofractionation experimental arm

Experimental group

Description:

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).

Treatment:

Radiation: Ultra-hypofractionation radiotherapy