Breast CancerPhase 3NCT03319069
Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
A Phase 3 study testing Hypofractionated radiotherapy and Conventional fractionated radiotherapy in people with Breast Cancer, run by Ahmed Ahm at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionated radiotherapy and Conventional fractionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut faculty of medicine , clinical oncology and nuclear medicine department
Asyut, 088
Nehal K Ali, M.S.C, 1002085589, ahmedabozeid185@yahoo.com
Hoda H Essa, M.D.
About this study
Official title: A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Hypofractionated radiotherapy, Conventional fractionated radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapyRadiation
Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region.
.
Conventional fractionated radiotherapyRadiation
50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Conventional fractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Frequency of local recurrence.
Comparison between the treatment groups.
Measured: 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.
Measured: two years
Histopathologic grades of the tumor.
Comparison between the two treatment groups.
Measured: one year
Pathological tumour size (pT stage classification)
cT 3-4
Measured: one year
Pathological node status (pN stage classification) (cN)
cN 2 (4 or more positive axillary lymph nodes.
Measured: one year
Frequency of distant metastasis
Compare two treatment groups regarding the frequency of distant metastasis.
Measured: two years
Secondary outcomes (1)
Overall survival.
Any deaths
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment Masking: open label
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Ahm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Ahm, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319069
- Sponsor's protocol ID
- 17200012
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase 3 Clinical Trial Of Postmastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer
- ClinicalTrials.gov ID
- NCT03319069
- Acronym / sponsor ID
- 17200012
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed AhmUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment Masking: open label
| Arm | Type | Receives |
|---|---|---|
| group (1) | Experimental | Radiation: Hypofractionated radiotherapyHypofractionated 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(2) | Active comparator | Radiation: Conventional fractionated radiotherapyConventional 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapyHypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region. . | Radiation | group (1) |
| Conventional fractionated radiotherapy50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region | Radiation | group(2) |
Primary outcome
Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse.
Time frame: two years
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.
Time frame: one year
Comparison between the treatment groups.
Toxicity outcome/ side affects that may occur with breast radiation therapy.
Time frame: two years
Comparison between the two treatment groups regarding breast irradiation toxicity outcomes and its frequency.
Histopathologic grades of the tumor.
Time frame: one year
Comparison between the two treatment groups.
Pathological tumour size (pT stage classification)
Time frame: one year
cT 3-4
Pathological node status (pN stage classification) (cN)
Time frame: one year
cN 2 (4 or more positive axillary lymph nodes.
Frequency of distant metastasis
Time frame: two years
Compare two treatment groups regarding the frequency of distant metastasis.
1 secondary outcome
Overall survival.
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionated radiotherapy and Conventional fractionated radiotherapy in people with Breast Cancer, run by Ahmed Ahm at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehal K Ali, M.S.C (1002085589, ahmedabozeid185@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional control rate ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse. (time frame: two years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.