Breast Cancer RadiotherapyPhase 3NCT05591456
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
A Phase 3 study testing adjuvant radiotherapy in people with Breast Cancer Radiotherapy, run by Zagazig University at 1 site in Egypt.
Trial summary
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Radiotherapy
- What is being tested?
- adjuvant 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 Jan 2018to 30 Jun 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological diagnosis of breast adenocarcinoma
- prior modified radical mastectomy
- negative resection margins (3 mm)
- pathological stage pT1-pT2, N0-2 (AJCC, 2017)
- no macroscopic evidence of distant metastases at diagnosis
- Age 18-80 years
- Normal hematological and biochemical laboratory tests
- Written informed consent was obtained from all patients
Who cannot join
- locally advanced disease pT3-pT4, N3
- positive surgical margins
- prior thoracic radiation
- synchronous second primary tumor
- distant metastases
- pregnancy
- presence of a concomitant psychiatric disorder precluding an aware informed consent.
- age >80 years
Trial locations and contacts
1 site in 1 country.
About this study
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule.
The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.
Read the detailed description
Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a baseline for use in further follow-up and to rule out metastasis. This includes detailed history taking, full physical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Setup, simulation and target definition For setup, patients were positioned on a wingboard with both arms raised above the head and radiopaque markers along breast borders. Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will be outlined. The planning of the tangential fields will be based on the target volume delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were separately contoured as organs at risk, the heart was outlined to the pulmonary trunk superiorly, including pericardium and excluding major vessels. For setup verification purposes, weekly digitally reconstructed radiographs (DRRs) were performed.
Evaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and overall survival.
During follow-up, patients are examined after completion of radiotherapy and at 3 and 6 months. Surveillance includes a full clinical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
Acute skin toxicity was assessed at the completion of radiotherapy and after 3 months (RTOG 2015), late skin toxicity was scored from 6 months after radiation and referred to the time of last examination (LENT/Soma Tables 1995). The maximal detected toxicity was scored according to the Common Terminology Criteria for Adverse Events, version 3.0, using the RTOG/EORTC toxicity scale associated with radiation as reference (NCI 2013) (Cox et al, 1995).
Admininistrative Design
Approvals for performing this study are obtained from:
- The recruited cases; B) The Institutional Review Board (IRB) RESULTS Collected data will be presented in tables and suitable graphs and analyzed using SSPS package. Mean and standard deviations will be estimated for quantitative data and median for non-normally distributed data. Actuarial or life tables analysis will be used for estimating survival and long-rank test for comparison of curves. P value is significant at 0.05 level.
- Conditions
- Breast Cancer Radiotherapy
- Being tested
- adjuvant radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant radiotherapyRadiation
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | The first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, Receives: Radiation: adjuvant radiotherapy |
| group 2 | Active comparator | the second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks. Receives: Radiation: adjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of breast shrinkage
breast size measured before and after radiotharapy
Measured: three months after radiotherapy
detection of breast shrinkage
breast size measured before and after radiotharapy
Measured: 6 months after radiotherapy
breast on the treated side is indurated
the induration detected by palpation with comparison with the normal side
Measured: 3 months after radiotherapy
detection of irregularity of breast shape
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
Measured: 3 months after radiotherapy
breast on the treated side is indurated
the induration detected by palpation with comparison with the normal side
Measured: 6 months after radiotherapy
detection of irregularity of breast shape
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
Measured: 6 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer RadiotherapyStudies of the same condition, open and under way.
- More trials run by Zagazig 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rawda Ahmed Abdul Hakim Balata, Zagazig University
- Investigators
- Rawda Balata, dr, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591456
- Sponsor's protocol ID
- Radiotherapy in Breast Cancer
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33538338Ash DV, Benson EA, Sainsbury JR, Round C, Head C. Seven-year follow-up on 334 patients treated by breast conserving surgery and short course radical postoperative radiotherapy: a report of the Yorkshire Breast Cancer Group. Clin Oncol (R Coll Radiol). 1995;7(2):93-6. doi: 10.1016/s0936-6555(05)80808-8.
PubMed 7619770Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522Fajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19.
PubMed 23572855Aleknavicius E, Atkocius V, Kuzmickiene I, Steponaviciene R. Postmastectomy internal mammary nodal irradiation: a long-term outcome. Medicina (Kaunas). 2014;50(4):230-6. doi: 10.1016/j.medici.2014.09.010. Epub 2014 Oct 7.
PubMed 25458960Mannino M, Yarnold JR. Shorter fractionation schedules in breast cancer radiotherapy: clinical and economic implications. Eur J Cancer. 2009 Mar;45(5):730-1. doi: 10.1016/j.ejca.2009.01.024. Epub 2009 Feb 23. No abstract available.
PubMed 19243933
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05591456
- Acronym / sponsor ID
- Radiotherapy in Breast Cancer
- Conditions
- Breast Cancer Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 24 Oct 2022 (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.
Accelerated hypofractionated 1 week post-mastectomy chest wall irradiation in breast cancer patients will presumably produce comparable toxicity and disease control in comparison to 3 weeks schedule.
The aim is to evaluate toxicity and disease control after implementation of accelerated hypofractionated 1 week chest wall irradiation in breast cancer patients.
Detailed description
Operational Design Patient Assessment Pre-radiotherapy assessment is done to provide a baseline for use in further follow-up and to rule out metastasis. This includes detailed history taking, full physical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
Treatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
Setup, simulation and target definition For setup, patients were positioned on a wingboard with both arms raised above the head and radiopaque markers along breast borders. Subsequently, the 5-mm slice-thick axial CT images were acquired from the lower mandible aspect to 5 cm below contralateral inframammary fold. The CT images will be automatically transferred to a planning workstation, where the CTV and relevant organs-at-risk (OARs) will be outlined. The planning of the tangential fields will be based on the target volume delineation for the dose-volume distribution analysis. The heart and ipsilateral lung were separately contoured as organs at risk, the heart was outlined to the pulmonary trunk superiorly, including pericardium and excluding major vessels. For setup verification purposes, weekly digitally reconstructed radiographs (DRRs) were performed.
Evaluation of Treatment Follow-up is done for assessment of toxicity and disease-free and overall survival.
During follow-up, patients are examined after completion of radiotherapy and at 3 and 6 months. Surveillance includes a full clinical examination, hematological and biochemical laboratory evaluation, tumor markers: CA15-3, plain chest X-ray, pelvi-abdominal ultrasound, ECHO for left cancer breast, bone scan if indicated.
Acute skin toxicity was assessed at the completion of radiotherapy and after 3 months (RTOG 2015), late skin toxicity was scored from 6 months after radiation and referred to the time of last examination (LENT/Soma Tables 1995). The maximal detected toxicity was scored according to the Common Terminology Criteria for Adverse Events, version 3.0, using the RTOG/EORTC toxicity scale associated with radiation as reference (NCI 2013) (Cox et al, 1995).
Admininistrative Design
Approvals for performing this study are obtained from:
- The recruited cases; B) The Institutional Review Board (IRB) RESULTS Collected data will be presented in tables and suitable graphs and analyzed using SSPS package. Mean and standard deviations will be estimated for quantitative data and median for non-normally distributed data. Actuarial or life tables analysis will be used for estimating survival and long-rank test for comparison of curves. P value is significant at 0.05 level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks.
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Radiation: adjuvant radiotherapyThe first group 50 patient (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, |
| group 2 | Active comparator | Radiation: adjuvant radiotherapythe second group 50 patient (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histological diagnosis of breast adenocarcinoma
- prior modified radical mastectomy
- negative resection margins (3 mm)
- pathological stage pT1-pT2, N0-2 (AJCC, 2017)
- no macroscopic evidence of distant metastases at diagnosis
Key exclusion criteria (8 listed)
- locally advanced disease pT3-pT4, N3
- positive surgical margins
- prior thoracic radiation
- synchronous second primary tumor
- distant metastases
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 |
|---|---|---|
| adjuvant radiotherapyTreatment schedule and delivery The patients who met the inclusion criteria were randomly divided into two groups, each group of 50 patients. The first group (arm A) will receive a dose of 27 Gy to the chest wall using 3D conformal radiotherapy (5.4 Gy per fraction) over one week, whilst, the second group (arm B) will receive a dose of 40 Gy to the chest wall (2.67 Gy per fraction) over three weeks. | Radiation | group 1, group 2 |
Primary outcome
detection of breast shrinkage
Time frame: three months after radiotherapy
breast size measured before and after radiotharapy
detection of breast shrinkage
Time frame: 6 months after radiotherapy
breast size measured before and after radiotharapy
breast on the treated side is indurated
Time frame: 3 months after radiotherapy
the induration detected by palpation with comparison with the normal side
detection of irregularity of breast shape
Time frame: 3 months after radiotherapy
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
breast on the treated side is indurated
Time frame: 6 months after radiotherapy
the induration detected by palpation with comparison with the normal side
detection of irregularity of breast shape
Time frame: 6 months after radiotherapy
change in the normal shape of the breast detected by inspection and photogaphing before and after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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 7619770Ash DV, Benson EA, Sainsbury JR, Round C, Head C. Seven-year follow-up on 334 patients treated by breast conserving surgery and short course radical postoperative radiotherapy: a report of the Yorkshire Breast Cancer Group. Clin Oncol (R Coll Radiol). 1995;7(2):93-6. doi: 10.1016/s0936-6555(05)80808-8.
- Background: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Background: PubMed 23572855Fajdic J, Djurovic D, Gotovac N, Hrgovic Z. Criteria and procedures for breast conserving surgery. Acta Inform Med. 2013 Mar;21(1):16-9. doi: 10.5455/AIM.2013.21.16-19.
- Background: PubMed 25458960Aleknavicius E, Atkocius V, Kuzmickiene I, Steponaviciene R. Postmastectomy internal mammary nodal irradiation: a long-term outcome. Medicina (Kaunas). 2014;50(4):230-6. doi: 10.1016/j.medici.2014.09.010. Epub 2014 Oct 7.
- Background: PubMed 19243933Mannino M, Yarnold JR. Shorter fractionation schedules in breast cancer radiotherapy: clinical and economic implications. Eur J Cancer. 2009 Mar;45(5):730-1. doi: 10.1016/j.ejca.2009.01.024. Epub 2009 Feb 23. No abstract available.
- Individual participant dataSharing planned: No
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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.
Rawda Balata, dr principal investigator
Zagazig University
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 adjuvant radiotherapy in people with Breast Cancer Radiotherapy, run by Zagazig 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 25 Oct 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of breast shrinkage (time frame: three months after radiotherapy). The study lists 6 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 NCT05591456, which also lists 6 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 25 Oct 2022.