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Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

NCT ID: NCT03319069

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assignment Masking: open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Check none

Study Groups

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group (1)

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.

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

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

.

group(2)

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.

Group Type ACTIVE_COMPARATOR

Conventional fractionated radiotherapy

Intervention Type RADIATION

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

Interventions

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Hypofractionated radiotherapy

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

.

Intervention Type RADIATION

Conventional fractionated radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ahmed Ahm

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Ahm

Dr.Hoda Hassan Mohammed Eisa, professor of clinical oncology and nuclear medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Assiut faculty of medicine , clinical oncology and nuclear medicine department

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Nehal K Ali, M.S.C

Role: CONTACT

Phone: 1002085589

Email: [email protected]

Facility Contacts

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Nehal K Ali, M.S.C

Role: primary

Other Identifiers

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17200012

Identifier Type: -

Identifier Source: org_study_id