Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

NCT03319069 | Unknown Phase 3

• 1 other identifier: 17200012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (7)

• 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

• Frequency of local recurrence.

  Comparison between the treatment groups.

  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.

  two years

• Histopathologic grades of the tumor.

  Comparison between the two treatment groups.

  one year

• Pathological tumour size (pT stage classification)

  cT 3-4

  one year

• Pathological node status (pN stage classification) (cN)

  cN 2 (4 or more positive axillary lymph nodes.

  one year

• Frequency of distant metastasis

  Compare two treatment groups regarding the frequency of distant metastasis.

  two years

Secondary Outcomes (1)

• Overall survival.

  two years

Study Arms (2)

group (1)

EXPERIMENTAL

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.

Radiation: Hypofractionated radiotherapy

group(2)

ACTIVE COMPARATOR

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.

Radiation: Conventional fractionated radiotherapy

Interventions

Hypofractionated radiotherapy RADIATION

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

group (1)

Conventional fractionated radiotherapy RADIATION

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

group(2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Ahm: lead

Study Sites (1)

Assiut faculty of medicine , clinical oncology and nuclear medicine department

Asyut, 088, Egypt

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Central Study Contacts

Nehal K Ali, M.S.C

CONTACT

1002085589; ahmedabozeid185@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Check none
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.Hoda Hassan Mohammed Eisa, professor of clinical oncology and nuclear medicine

Model Details: Assignment Masking: open label

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 24, 2017
• Study Start: October 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

EG (1)