Breast CancerPhase 2NCT04580784
Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer
A Phase 2 study testing Weekly hypofractionation for early breast cancer in people with Breast Cancer and Radiotherapy Side Effect, run by Mona Salem at 1 site in Egypt.
Trial summary
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy Side Effect
- What is being tested?
- Weekly hypofractionation for early breast cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2018to May 2024
- Phase
- Phase 2
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of invasive breast adenocarcinoma.
- Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
- No macroscopic evidence of distant metastases at diagnosis.
Who cannot join
- Prior radiation to the thoracic region.
- Pregnancy.
- Patients with synchronous or prior malignancy.
- Positive surgical margins.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El AiniH
Cairo
Dean's office, 002025729584, Dean@kasralainy.edu.eg
About this study
Official title: Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
Read the detailed description
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Being tested
- Weekly hypofractionation for early breast cancer
- Keywords
- Breast cancer, Radiotherapy, Hypofractionation
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly hypofractionation for early breast cancerRadiation
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionation | Experimental | Hypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions. Receives: Radiation: Weekly hypofractionation for early breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cosmetic breast appearance
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Measured: six months
Acute radiation toxicity assessment
according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.
Measured: six months
Patient quality of life assessment.
according to FACT-B
Measured: six months
Patient satisfaction.
according to FACIT-TS-PS
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start10 Dec 2018
- Primary completionNov 2020 (estimated)
- Study completionMay 2024 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona Salem
- Sponsor type
- University, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Responsible party
- Sponsor-investigator, Mona Salem, Kasr El Aini Hospital
- Investigators
- Mona Salem, MSc, Principal investigator, Kasr El AiniH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580784
- Sponsor's protocol ID
- FAST feasibility in CU
- Status last verified
- Oct 2020
- First submitted
- 7 Jun 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
- ClinicalTrials.gov ID
- NCT04580784
- Acronym / sponsor ID
- FAST feasibility in CU
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Keywords
- Breast cancer, Radiotherapy, Hypofractionation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mona SalemUniversity, hospital or other
- Collaborators
- Kasr El Aini Hospital
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 8 Oct 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.
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
Detailed description
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypofractionation | Experimental | Radiation: Weekly hypofractionation for early breast cancerHypofractionated whole breast radiotherapy using a dose of 28.5 Gy over 5 fractions with once weekly fractions. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven diagnosis of invasive breast adenocarcinoma.
- Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
- No macroscopic evidence of distant metastases at diagnosis.
Key exclusion criteria (4 listed)
- Prior radiation to the thoracic region.
- Pregnancy.
- Patients with synchronous or prior malignancy.
- Positive surgical 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 |
|---|---|---|
| Weekly hypofractionation for early breast cancerTesting the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks | Radiation | Hypofractionation |
Primary outcome
Change in cosmetic breast appearance
Time frame: six months
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Acute radiation toxicity assessment
Time frame: six months
according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.
Patient quality of life assessment.
Time frame: six months
according to FACT-B
Patient satisfaction.
Time frame: six months
according to FACIT-TS-PS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- 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.
Mona Salem, MSc principal investigator
Kasr El AiniH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Weekly hypofractionation for early breast cancer in people with Breast Cancer and Radiotherapy Side Effect, run by Mona Salem 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 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 8 Oct 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mona M Salem, MSc (00201007731412, mona.m.salem@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cosmetic breast appearance (time frame: six 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?
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 8 Oct 2020.