Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03319069
• Other study ID #: 17200012
• Status: Recruiting
• Phase: Phase 3
• First received: October 2, 2017
• Last updated: October 22, 2017
• Start date: October 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2017
• Source: Assiut University
• Contact: Nehal K Ali, M.S.C
• Phone: 1002085589
• Email: ahmedabozeid185[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Hypofractionated radiotherapy
Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region.
• Conventional fractionated radiotherapy
50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region

Locations

Country	Name	City	State
Egypt	Assiut faculty of medicine , clinical oncology and nuclear medicine department	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Ahm

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	two years
Primary	Frequency of local recurrence.	Comparison between the treatment groups.	one year
Primary	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.	two years
Primary	Histopathologic grades of the tumor.	Comparison between the two treatment groups.	one year
Primary	Pathological tumour size (pT stage classification)	cT 3-4	one year
Primary	Pathological node status (pN stage classification) (cN)	cN 2 (4 or more positive axillary lymph nodes.	one year
Primary	Frequency of distant metastasis	Compare two treatment groups regarding the frequency of distant metastasis.	two years
Secondary	Overall survival.	Any deaths	two years