Breast CarcinomaNCT05150535
One Week Adjuvant Radiotherapy for Breast Cancer
A study testing Hypofractionation Radiotherapy. and Ultra-hypofractionation radiotherapy in people with Breast Carcinoma, run by Sohag University at 1 site in Egypt.
Trial summary
Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth. Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and… Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Hypofractionation Radiotherapy. and Ultra-hypofractionation radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Oct 2023
- Phase
- Interventional
- 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 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.
- Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.
- All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy
Who cannot join
- Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.
- Postoperative positive margin.
- Carcinomas in situ.
- Mesenchymal breast lesions.
- Locoregional recurrent breast cancer.
- Synchronous bilateral breast cancer.
- very early breast cancer (T1-2N0M0,T1N1M0).
Trial locations and contacts
1 site in 1 country.
Mohamed S gaber, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ElSherif, professor
About this study
Official title: A Prospective Study of One Week Accelerated Hypo-fractionation Adjuvant Radiotherapy in High-risk Breast Cancer Patients
- Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth.
- Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer.
- More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.
- Conditions
- Breast Carcinoma
- Being tested
- Hypofractionation Radiotherapy., Ultra-hypofractionation 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.
Hypofractionation Radiotherapy.Radiation
Also called 3 weeks radiotherapy.
Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.
Ultra-hypofractionation radiotherapyRadiation
Also called 1 week accelerated hypo-fractionation radiotherapy
Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation control arm | Active comparator | Patients who will receive 40 Gy in 15 fractions to the entire breast or chest wall over three weeks and have had breast conservation surgery (BCS) or oncoplastic breast surgery(OBS) will receive an additional boost to the tumour site if and will receive sequential dose 12GY\4 fractions or SIB 8GY 15 fractions. The supraclavicular fossa will be treated in patients with node-positive disease or those who had received neoadjuvant chemotherapy . The IMLN will be irradiated in N2and N3 at first presentation. Receives: Radiation: Hypofractionation Radiotherapy. |
| . Ultrahypofractionation experimental arm | Experimental | Patients who will receive 26 Gy in 5 fractions to the entire breast and or chest wall for one week only. The volume of this arm will be the same as the volume of the control arm as regard axillary nodes, supraclavicular and IMLN. Patients who have had breast conservation or oncoplastic breast surgery(OBS) will be given a boost. If a boost is given, SIB of 6 Gy in 5 fractions will be used (or a sequential boost of 12GY\4 fractions). Receives: Radiation: Ultra-hypofractionation radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE).
Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.
Measured: 3 months
Chronic toxicity
Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years.
Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.
Measured: 6 months post treatment up to 2 years
Local recurrence
Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.
Measured: Up to 2 years
Patient compliance
Compliance to treatment (number of interrupted days of radiotherapy.
Measured: From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm
Secondary outcomes (1)
Overall survival
Overall survival (Number of the surviving patients for 2 years in each arm of the study)
Measured: From time of diagnosis up to 2 years post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Elmahdy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150535
- Sponsor's protocol ID
- Soh-Med-21_10_18
- Status last verified
- May 2022
- First submitted
- 3 Nov 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Gany F, Ayash C, Raad N, Wu M, Roberts-Eversley N, Mahmoud H, Fouad Y, Fahmy Y, Asar H, Salama A, El-Shinawi M. Financial and food security challenges of Egyptian women undergoing breast cancer treatment. Support Care Cancer. 2020 Dec;28(12):5787-5794. doi: 10.1007/s00520-020-05426-9. Epub 2020 Mar 27.
PubMed 32221669Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.
PubMed 31040712Stapleton SM, Oseni TO, Bababekov YJ, Hung YC, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. 2018 Jun 1;153(6):594-595. doi: 10.1001/jamasurg.2018.0035.
PubMed 29516087
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of One Week Accelerated Hypo-fractionation Adjuvant Radiotherapy in High-risk Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05150535
- Acronym / sponsor ID
- Soh-Med-21_10_18
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 Dec 2021 (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.
- Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth.
- Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer.
- More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation control arm | Active comparator | Radiation: Hypofractionation Radiotherapy.Patients who will receive 40 Gy in 15 fractions to the entire breast or chest wall over three weeks and have had breast conservation surgery (BCS) or oncoplastic breast surgery(OBS) will receive an additional boost to the tumour site if and will receive sequential dose 12GY\4 fractions or SIB 8GY 15 fractions. The supraclavicular fossa will be treated in patients with node-positive disease or those who had received neoadjuvant chemotherapy . The IMLN will be irradiated in N2and N3 at first presentation. |
| . Ultrahypofractionation experimental arm | Experimental | Radiation: Ultra-hypofractionation radiotherapyPatients who will receive 26 Gy in 5 fractions to the entire breast and or chest wall for one week only. The volume of this arm will be the same as the volume of the control arm as regard axillary nodes, supraclavicular and IMLN. Patients who have had breast conservation or oncoplastic breast surgery(OBS) will be given a boost. If a boost is given, SIB of 6 Gy in 5 fractions will be used (or a sequential boost of 12GY\4 fractions). |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.
- Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.
- All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy
Key exclusion criteria (7 listed)
- Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.
- Postoperative positive margin.
- Carcinomas in situ.
- Mesenchymal breast lesions.
- Locoregional recurrent breast cancer.
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 |
|---|---|---|
| Hypofractionation Radiotherapy.Also: 3 weeks radiotherapy.Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks. | Radiation | Hypofractionation control arm |
| Ultra-hypofractionation radiotherapyAlso: 1 week accelerated hypo-fractionation radiotherapyPatients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week. | Radiation | . Ultrahypofractionation experimental arm |
Primary outcome
Acute toxicity
Time frame: 3 months
Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.
Chronic toxicity
Time frame: 6 months post treatment up to 2 years
Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.
Local recurrence
Time frame: Up to 2 years
Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.
Patient compliance
Time frame: From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm
Compliance to treatment (number of interrupted days of radiotherapy.
1 secondary outcome
Overall survival
Time frame: From time of diagnosis up to 2 years post radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 32221669Gany F, Ayash C, Raad N, Wu M, Roberts-Eversley N, Mahmoud H, Fouad Y, Fahmy Y, Asar H, Salama A, El-Shinawi M. Financial and food security challenges of Egyptian women undergoing breast cancer treatment. Support Care Cancer. 2020 Dec;28(12):5787-5794. doi: 10.1007/s00520-020-05426-9. Epub 2020 Mar 27.
- Background: PubMed 31040712Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.
- Background: PubMed 29516087Stapleton SM, Oseni TO, Bababekov YJ, Hung YC, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. 2018 Jun 1;153(6):594-595. doi: 10.1001/jamasurg.2018.0035.
- Individual participant dataSharing planned: Yes
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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.
Mohamed S gaber, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionation Radiotherapy. and Ultra-hypofractionation radiotherapy in people with Breast Carcinoma, run by Sohag University 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 3 inclusion and 7 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 9 May 2022. 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.
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 Nahla M Elmahdy, assistant lecturer (01026886840, nahla.youssif@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150535, which also lists 4 linked publications.
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 9 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.