Breast CancerNCT04434677
Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
A study testing Hypofractionation and ultraHypofractionation in people with Breast Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionation and ultraHypofractionation
- 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
- 28 Jun 2019to 28 Jun 2021
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years old.
- Informed consent.
- Either breast conservative surgery or mastectomy.
- Invasive breast cancer with p T1-3, p N0-2.
- Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
Who cannot join
- Evidence of distant metastases.
- Prior irradiation.
- Inflammatory breast cancer.
- Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
- Tumor with positive margins.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
ACOD
Alexandria
Abdelaziz Belal, PHD, +201223318257, abdelazizbelal@hotmail.com
About this study
Official title: Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
Read the detailed description
In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.
The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
- Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
- Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively
- Conditions
- Breast Cancer
- Being tested
- Hypofractionation, ultraHypofractionation
- Keywords
- radiotherapy, hypofractionation, ultrahypofractionation, 5 fractions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypofractionationRadiation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
ultraHypofractionationRadiation
3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation | Active comparator | Control arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks Receives: Radiation: Hypofractionation |
| Ultrahypofractionation | Experimental | Experimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks Receives: Radiation: ultraHypofractionation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
Measured: Start of treatment till 3 months from end of treatment
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Measured: Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Rate of Ipsilateral local tumor recurrence
Local recurrence proved by image and biopsy
Measured: 1 to 2 years
Compliance to treatment (number of interrupted days of radiation)
Treatment interruptions of planned cycles
Measured: Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Secondary outcomes (1)
Overall survival
the percentage of people in a study or treatment group who are alive two years after the start of treatment.
Measured: From date of diagnosis up to average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start28 Jun 2019
- Primary completion28 Jun 2021 (estimated)
- Study completion28 Jun 2021 (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.
- More trials run by Alexandria 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
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf M El-Enbaby, Prof, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434677
- Sponsor's protocol ID
- 0201263
- Status last verified
- Mar 2021
- First submitted
- 29 May 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Hypofractionation And Ultra-Hypofractionation In Adjuvant Radiotherapy For Breast Cancer
- ClinicalTrials.gov ID
- NCT04434677
- Acronym / sponsor ID
- 0201263
- Conditions
- Breast Cancer
- Keywords
- radiotherapy, hypofractionation, ultrahypofractionation, 5 fractions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 28 Jun 2021 (estimated)
- Study completion
- 28 Jun 2021 (estimated)
- First posted
- 17 Jun 2020 (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.
Prospective randomized study comparing 5 fractions in alternative days to standard 15 fractions regarding effectiveness and feasibility during adjuvant treatment in breast caner patients aged above 50 years
Detailed description
In Alexandria, the number of working linear machines are limited with overcrowded waiting list which lead to prolongation of overall treatment time and delay in starting radiotherapy. Providing the available data, Principle investigator is conducting this study in parallel with fast forward protocol to provide an alternative cost effective approach to patients.
The rationale behind hypofractionation depends mainly on the alpha beta ratio (α/β) and the overall treatment time. In Breast cancer the ratio is around 4 which is slightly lower than other tumors such as head and neck. The lower the ratio the higher the dose per fraction is needed to compensate slower proliferating tumors. Also, the overall treatment time could affect the local recurrence of breast cancer which is increased with long duration of treatment.
This study will include at least 100 patients with non metastatic histologically proved breast cancer who are indicated for adjuvant radiotherapy.
The patients will be randomized into two arms:
- Control arm: will include 50 patients who will receive standard 40.05 Gray (2.67 Gy/fx) over 15 fractions with or without boost over 3 weeks biologically effective dose (BED) for early and late effect equal 50.74.Gy10 and 75.69 Gy3 respectively.
- Experimental arm: will include 50 patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks with BED for early and late effect equal 39.52 Gy10 and 71.07 Gy3 respectively
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation | Active comparator | Radiation: HypofractionationControl arm:patients who will receive standard 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks |
| Ultrahypofractionation | Experimental | Radiation: ultraHypofractionationExperimental arm: Patients who will receive 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥50 years old.
- Informed consent.
- Either breast conservative surgery or mastectomy.
- Invasive breast cancer with p T1-3, p N0-2.
- Non metastatic breast cancer proven by clinical examinations and imaging (X-ray chest and ultrasound or CT scan chest and abdomen).
Key exclusion criteria (5 listed)
- Evidence of distant metastases.
- Prior irradiation.
- Inflammatory breast cancer.
- Tumor with T4 (skin nodules or fixed to chest wall or ulceration).
- Tumor with positive margins.
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 |
|---|---|---|
| Hypofractionation3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks | Radiation | Hypofractionation |
| ultraHypofractionation3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks | Radiation | Ultrahypofractionation |
Primary outcome
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE)
Time frame: Start of treatment till 3 months from end of treatment
Each patient will be assessed weekly during radiotherapy and monthly for three months post radiotherapy to assess acute toxicity and will be documented according to Common Terminology Criteria for adverse events (CTCAE)
Rate of chronic Toxicity grade 2 or higher (NCI-CTCAE)
Time frame: Before start treatment and from 6 months after finishing treatment every 6 months up to average 2 years
Each patient will be assessed before treatment and at 6 , 12 , 24 months for chronic toxicity Criteria for adverse events (CTCAE)
Rate of Ipsilateral local tumor recurrence
Time frame: 1 to 2 years
Local recurrence proved by image and biopsy
Compliance to treatment (number of interrupted days of radiation)
Time frame: Start treatment till end of treatment (2 weeks in arm one and 3 weeks in arm2)
Treatment interruptions of planned cycles
1 secondary outcome
Overall survival
Time frame: From date of diagnosis up to average 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
Ashraf M El-Enbaby, Prof principal investigator
Alexandria University
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 and ultraHypofractionation in people with Breast Cancer, run by Alexandria 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 5 inclusion and 5 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 1 Apr 2021. 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 Amr Munir (+201227241185, dr.amr.munir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Acute grade 2 or higher toxicity (NCI-CTCAE) (time frame: Start of treatment till 3 months from end of treatment). 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?
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 1 Apr 2021.