Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Ahmed Ahm

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: Conventional fractionated radiotherapy; Radiation: Hypofractionated radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03319069

17200012

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and toxicities of hypofractionated radiotherapy with conventional fractionated radiotherapy in high risk breast cancer patients treated with mastectomy. It's hypothesized that the efficacy and toxicities are similar between the two groups.

Full description

Eligible breast cancer patients with mastectomy and axillary dissection are divided into two groups: conventional fractionated (CF) radiotherapy of 50 Gray (GY) in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region, and hypofractionated (HF) radiotherapy of 43.5 Gray (GY) in 15 fractions within 3 weeks to the same region. During and after radiotherapy , the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer
• Undergone total mastectomy and axillary dissection T 3-4 and/or 4 or more positive axillary lymph nodes.
• Fit for chemotherapy ( if indicated) , endocrine therapy (if indicated), and postoperative irradiation.
• Written informed concent.
• C T3-4 , or C N2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy.
• No supraclavicular or internal mammary nodes metastases.
• No distant metastases .Enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who did't receive neoadjuvant therapy.
• Enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and did't need adjuvant chemotherapy.

Exclusion criteria

• Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
• Previous or concurrent malignant other than non melanomatous skin cancer
• Bilateral breast cancer.
• Immediate or delayed ipsilateral breast cancer reconstruction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

group (1)

Experimental group

Description:

Hypofractionated radiotherapy women with T3-4 and /or 4 or more axillary nodes involvement post mastectomy. Hypofractionated radiotherapy 43,5 GY/15 fractions (f) /3w. to chest wall and supraclavicular nodal region.

Treatment:

Radiation: Hypofractionated radiotherapy

group(2)

Active Comparator group

Description:

Conventional fractionated radiotherapy breast cancer women with T3-4 and/ or 4 or more axillary nodes involvement post mastectomy. Conventional fractionated radiotherapy 50 Gray(GY)/25 fractions (f)/5w to chest wall and supraclavicular nodal region.

Treatment:

Radiation: Conventional fractionated radiotherapy