Clinical trial NCT03319069: Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
Official title: A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment Masking: open label
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.
timeFrame: two years
measure: Frequency of local recurrence.
timeFrame: one year
measure: Toxicity outcome/ side affects that may occur with breast radiation therapy.
timeFrame: two years
measure: Histopathologic grades of the tumor.
timeFrame: one year
measure: Pathological tumour size (pT stage classification)
timeFrame: one year
measure: Pathological node status (pN stage classification) (cN)
timeFrame: one year
measure: Frequency of distant metastasis
timeFrame: two years
Secondary outcomes:
measure: Overall survival.
timeFrame: two years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut faculty of medicine , clinical oncology and nuclear medicine department
Study officials:
References: