Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Phase 3UnknownNCT03319069

Ahmed Ahm60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Hypofractionated radiotherapyRADIATION

Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. .

Conventional fractionated radiotherapyRADIATION

50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assiut faculty of medicine , clinical oncology and nuclear medicine department

Asyut, Egypt

RECRUITING

Outcomes

Primary Outcomes

Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.

60 female patients with high risk post mastectomy breast cancer will divided randomly into two equal groups One group will received hypofractionated (HF) regimen of postoperative radiotherapy, and group two will receive conventional fractionated (CF) regimen of postoperative local radiotherapy. in high risk breast cancer , comparison between the two treated groups.

Time frame: two years

Frequency of local recurrence.

Comparison between the treatment groups.

Time frame: one year

Toxicity outcome/ side affects that may occur with breast radiation therapy.

Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency.

Time frame: two years

Histopathologic grades of the tumor.

Comparison between the two treatment groups.

Time frame: one year

Pathological tumour size (pT stage classification)

cT 3-4

Time frame: one year

Pathological node status (pN stage classification) (cN)

cN 2 (4 or more positive axillary lymph nodes.

Time frame: one year

Frequency of distant metastasis

Compare two treatment groups regarding the frequency of distant metastasis.

Time frame: two years

Secondary Outcomes

Central Contacts

Nehal K Ali, M.S.C

CONTACT

1002085589 ahmedabozeid185@yahoo.com

Data from ClinicalTrials.gov

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