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Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Hypofractionated radiotherapy
Conventional fractionated radiotherapy
Sponsored by
Ahmed Ahm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Assiut faculty of medicine , clinical oncology and nuclear medicine departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group (1)

group(2)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
Frequency of local recurrence.
Comparison between the treatment groups.
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.
Histopathologic grades of the tumor.
Comparison between the two treatment groups.
Pathological tumour size (pT stage classification)
cT 3-4
Pathological node status (pN stage classification) (cN)
cN 2 (4 or more positive axillary lymph nodes.
Frequency of distant metastasis
Compare two treatment groups regarding the frequency of distant metastasis.

Secondary Outcome Measures

Overall survival.
Any deaths

Full Information

First Posted
October 2, 2017
Last Updated
October 22, 2017
Sponsor
Ahmed Ahm
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1. Study Identification

Unique Protocol Identification Number
NCT03319069
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Ahm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Assignment Masking: open label
Masking
None (Open Label)
Masking Description
Check none
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group (1)
Arm Type
Experimental
Arm 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.
Arm Title
group(2)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiotherapy
Intervention Description
Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. .
Intervention Type
Radiation
Intervention Name(s)
Conventional fractionated radiotherapy
Intervention Description
50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region
Primary Outcome Measure Information:
Title
Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.
Description
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
Title
Frequency of local recurrence.
Description
Comparison between the treatment groups.
Time Frame
one year
Title
Toxicity outcome/ side affects that may occur with breast radiation therapy.
Description
Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency.
Time Frame
two years
Title
Histopathologic grades of the tumor.
Description
Comparison between the two treatment groups.
Time Frame
one year
Title
Pathological tumour size (pT stage classification)
Description
cT 3-4
Time Frame
one year
Title
Pathological node status (pN stage classification) (cN)
Description
cN 2 (4 or more positive axillary lymph nodes.
Time Frame
one year
Title
Frequency of distant metastasis
Description
Compare two treatment groups regarding the frequency of distant metastasis.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Overall survival.
Description
Any deaths
Time Frame
two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nehal K Ali, M.S.C
Phone
1002085589
Email
ahmedabozeid185@yahoo.com
Facility Information:
Facility Name
Assiut faculty of medicine , clinical oncology and nuclear medicine department
City
Assiut
ZIP/Postal Code
088
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nehal K Ali, M.S.C
Phone
1002085589
Email
ahmedabozeid185@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hoda H Essa, M.D.
First Name & Middle Initial & Last Name & Degree
Abeer F Amin, M.D.

12. IPD Sharing Statement

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Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

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