Female Breast CancerNCT05586256
Ultra-hypofractionated Radiotherapy in Breast Cancer Patients
An observational study of Female Breast Cancer, run by University Of Perugia at 1 site in Italy.
Trial summary
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Female Breast Cancer
- What is being tested?
- ultra-hypofractionated whole breast irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2021to 21 Jul 2026
- Phase
- Observational
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by early stage breast cancer (both invasive and ductal carcinoma in situ) receiving ultra-hypofractionated whole breast irradiation (with or without a tumor bed boost) after breast conserving surgery. Main exclusion critereria are mastectomy and regional nodal irradiation .Neoadjuvant and/or adjuvant systemic therapies are allowed.
Who may be able to join
- Female patients
- Age ≥ 18 years.
- Early stage breast cancer treated with breast conserving surgery
- Whole breast irradiation without regional nodal irradiation
- Infiltrating carcinomas
- CDIS
- Written informed consent
Who cannot join
- Age<18 years.
- Regional nodal radiotherapy.
- Distant metastases.
- Previous history of malignancy except basaloid skin tumours and CIN. Previous history of breast cancer is not an exclusion criteria if treated with curative intent and if patient is disease free at least 5 years from diagnosis.
- Presence of absolute radiotherapy contraindications (pregnancy, inability to maintain the correct treatment position) and relative radiotherapy contraindications (connective tissue diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, dermatomyositis and vasculitis, especially if the disease is in an active phase)
- Patient's refusal to use data for research purposes.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia
Perugia, 06132
Cynthia Aristei, MD, +390755783254, cynthia.aristei@unipg.it
Isabella Palumbo, MD, +390755783254, isabella.palumbo@unipg.it
About this study
Official title: Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice.
Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
Read the detailed description
The present multicenter retrospective and prospective observational study aims to evaluate feasibility, toxicity, efficacy, cosmetic outcome and QoL in early stage BC patients treated with BC followed by ultra-hypofractionated WBI (with or without a tumor bed boost). This study was designed to confirm literature data (FAST-Forward trial) in the clinical practice ("real life"study). All enrolled patients will be treated with an ultra-hypofractionated WBI schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole breast irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre. Main exclusion criteria are mastectomy and needs for regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed.
The primary outcome of this study is acute and chronic toxicity evaluation. Secondary outcomes are: OS, DFS, rates of local and loco-regional recurrence, distant metastasis occurence, cosmetic outcome and QoL assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0 at each follow-up visit.
Regarding prospectively enrolled patient cosmetic assessment will be graded (by the physician and the patient) according to the Harvard scale and performed before the start of radiotherapy (RT), 6 months and 1, 2 and 5 years after the end of RT; frontal photographs of both breasts will be taken before the start of R, 6 months and 1, 2 and 5 years after the end of RT. In particular, two photographs will be taken of the patient's trunk region, one with the hands resting on the hips, the other with the arms raised above the head (avoiding patients face). Photographic documentation will be evaluated according to the consensus scoring method described by Haviland et al. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 will be administered before the start of RT,1 month after the end of RT and then at 1, 2 and 5 years after the end of RT.
Follow-up visits are scheduled as follows: one month after the end of RT and then every 4-6 months for 5 years. Laboratory test (blood count, biochemical, with or without CEA and Ca15.3), mammography and breast ultrasound scans will be scheduled 4-6 months after the end of RT and then yearly. Additional exams will be prescribed during the follow up in order to detected any disease reccurence.
- Conditions
- Female Breast Cancer
- Being tested
- ultra-hypofractionated whole breast irradiation
- Keywords
- early stage breast cancer, breast conserving surgery, ultra-hypofractionated whole breast irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-hypofractionated whole breast irradiationRadiation
All enrolled patients will be treated with an ultra-ipofractionated whole breast irradiation schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole bresat irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre.
Main exclusion critereria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
Evaluation of acute toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Measured: 1-6 months after RT
Late toxicity
Evaluation of chronic late toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Late will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Measured: from 6 months after RT to 60 months
Secondary outcomes (8)
overall survival
overall survival
Measured: 1 month after RT and then every 4-6 months for 5 years
disease-free survival
disease-free survival
Measured: 1 month after RT and then every 4-6 months for 5 years
rates of local and loco-regional recurrence
rates of local and loco-regional recurrence
Measured: 1 month after RT and then every 4-6 months for 5 years
distant metastasis occurence
distant metastasis occurence
Measured: 1 month after RT and then every 4-6 months for 5 years
cosmetic outcome
Breast cosmetic result will be graded according to Harvard scale of breast cosmesis (1. Excellent - 2. Good - 3. Fair - 4. Poor)
Measured: at baseline and then after 6 months and then 1, 2 and 5 years
QoL assessment
EORTC QLQ-C30
Measured: at baseline and then after 6 months and then 1, 2 and 5 years
QoL assessment
EORTC-QLQ-BR23
Measured: at baseline and then after 6 months and then 1, 2 and 5 years
photographic assessment
consensus scoring method described by Haviland et al.
Measured: at baseline and then after 6 months and then 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start21 Jul 2021
- Primary completion21 Jul 2023 (estimated)
- Study completion21 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Aristei, University Of Perugia
- Investigators
- Cynthia Aristei, MD, Principal investigator, Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586256
- Sponsor's protocol ID
- FAST-F-PG01
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mariam NBG, Song YP, Joseph N, Hoskin P, Reeves K, Porta N, James N, Choudhury A. Hypofractionation: less is more? Oncotarget. 2021 Aug 17;12(17):1729-1733. doi: 10.18632/oncotarget.28023. eCollection 2021 Aug 17.
PubMed 34434502Haviland JS, Ashton A, Broad B, Gothard L, Owen JR, Tait D, Sydenham MA, Yarnold JR, Bliss JM. Evaluation of a method for grading late photographic change in breast appearance after radiotherapy for early breast cancer. Clin Oncol (R Coll Radiol). 2008 Sep;20(7):497-501. doi: 10.1016/j.clon.2008.03.017. Epub 2008 May 27.
PubMed 18502105Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. No abstract available.
PubMed 110740
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05586256
- Acronym / sponsor ID
- FAST-F-PG01
- Conditions
- Female Breast Cancer
- Keywords
- early stage breast cancer, breast conserving surgery, ultra-hypofractionated whole breast irradiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 21 Jul 2023 (estimated)
- Study completion
- 21 Jul 2026 (estimated)
- First posted
- 19 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.
The present multicenter, retrospective and prospective observational study, aims to evaluate an ultra-hypofractionated whole breast irradiation schedule (WBI, 26 Gy in 5 fractions), in order to confirm literature data (FAST-F study) in the clinical practice.
Patient population included women affected by early stage breast cancer (BC), both invasive and ductal carcinoma in situ, receiving ultra-hypofractionated WBI (with or without a tumor bed boost) after breast conserving surgery (BCS). Main exclusion criteria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. The primary otcome is acute and chronic toxicity evaluation. Secondary outcomes are: overall servival (OS), disease-free survival (DFS), rates of local and loco-regional recurrences, distant metastasis occurrence, cosmetic outcome and quality of life (QoL) assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0. Cosmetic assessment will be graded according to the Harvard scale. Frontal photographs of both breasts will be used to evaluate toxicity and cosmetic results. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 questionnaires will be administered.
Detailed description
The present multicenter retrospective and prospective observational study aims to evaluate feasibility, toxicity, efficacy, cosmetic outcome and QoL in early stage BC patients treated with BC followed by ultra-hypofractionated WBI (with or without a tumor bed boost). This study was designed to confirm literature data (FAST-Forward trial) in the clinical practice ("real life"study). All enrolled patients will be treated with an ultra-hypofractionated WBI schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole breast irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre. Main exclusion criteria are mastectomy and needs for regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed.
The primary outcome of this study is acute and chronic toxicity evaluation. Secondary outcomes are: OS, DFS, rates of local and loco-regional recurrence, distant metastasis occurence, cosmetic outcome and QoL assessment. Acute and late toxicities will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0 at each follow-up visit.
Regarding prospectively enrolled patient cosmetic assessment will be graded (by the physician and the patient) according to the Harvard scale and performed before the start of radiotherapy (RT), 6 months and 1, 2 and 5 years after the end of RT; frontal photographs of both breasts will be taken before the start of R, 6 months and 1, 2 and 5 years after the end of RT. In particular, two photographs will be taken of the patient's trunk region, one with the hands resting on the hips, the other with the arms raised above the head (avoiding patients face). Photographic documentation will be evaluated according to the consensus scoring method described by Haviland et al. For QoL assessment the EORTC (European Organisation for Research and Treatment of Cancer), QLQ-C30 and EORTC-QLQ-BR23 will be administered before the start of RT,1 month after the end of RT and then at 1, 2 and 5 years after the end of RT.
Follow-up visits are scheduled as follows: one month after the end of RT and then every 4-6 months for 5 years. Laboratory test (blood count, biochemical, with or without CEA and Ca15.3), mammography and breast ultrasound scans will be scheduled 4-6 months after the end of RT and then yearly. Additional exams will be prescribed during the follow up in order to detected any disease reccurence.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by early stage breast cancer (both invasive and ductal carcinoma in situ) receiving ultra-hypofractionated whole breast irradiation (with or without a tumor bed boost) after breast conserving surgery. Main exclusion critereria are mastectomy and regional nodal irradiation .Neoadjuvant and/or adjuvant systemic therapies are allowed.
Key inclusion criteria (7 listed)
- Female patients
- Age ≥ 18 years.
- Early stage breast cancer treated with breast conserving surgery
- Whole breast irradiation without regional nodal irradiation
- Infiltrating carcinomas
Key exclusion criteria (6 listed)
- Age<18 years.
- Regional nodal radiotherapy.
- Distant metastases.
- Previous history of malignancy except basaloid skin tumours and CIN. Previous history of breast cancer is not an exclusion criteria if treated with curative intent and if patient is disease free at least 5 years from diagnosis.
- Presence of absolute radiotherapy contraindications (pregnancy, inability to maintain the correct treatment position) and relative radiotherapy contraindications (connective tissue diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, dermatomyositis and vasculitis, especially if the disease is in an active phase)
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 |
|---|---|---|
| ultra-hypofractionated whole breast irradiationAll enrolled patients will be treated with an ultra-ipofractionated whole breast irradiation schedule (26 Gy delivered in 5 consecutive fractions, single dose 5.2 Gy), according to FAST-Forward trial. Whole bresat irradiation should be followed or not by a tumor bed boost (sequential: 7.6 Gy in 2 consecutive fractions, single dose 3.8 Gy or simultaneous intergrated boost: 30 Gy in 5 consecutive fractions, single dose 6 Gy). Either three-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT) or helicoildal techniques are allowed. Breath control techniques may be used at the discretion of each partecipating centre. Main exclusion critereria are mastectomy and regional nodal irradiation. Neoadjuvant and/or adjuvant systemic therapies are allowed. | Radiation | – |
Primary outcome
Acute toxicity
Time frame: 1-6 months after RT
Evaluation of acute toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
Late toxicity
Time frame: from 6 months after RT to 60 months
Evaluation of chronic late toxicity to confirm the results obtained in the prospective randomized FAST-Forward study. Late will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0
8 secondary outcomes
overall survival
Time frame: 1 month after RT and then every 4-6 months for 5 years
disease-free survival
Time frame: 1 month after RT and then every 4-6 months for 5 years
rates of local and loco-regional recurrence
Time frame: 1 month after RT and then every 4-6 months for 5 years
distant metastasis occurence
Time frame: 1 month after RT and then every 4-6 months for 5 years
cosmetic outcome
Time frame: at baseline and then after 6 months and then 1, 2 and 5 years
QoL assessment
Time frame: at baseline and then after 6 months and then 1, 2 and 5 years
QoL assessment
Time frame: at baseline and then after 6 months and then 1, 2 and 5 years
photographic assessment
Time frame: at baseline and then after 6 months and then 1, 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Background: PubMed 34434502Mariam NBG, Song YP, Joseph N, Hoskin P, Reeves K, Porta N, James N, Choudhury A. Hypofractionation: less is more? Oncotarget. 2021 Aug 17;12(17):1729-1733. doi: 10.18632/oncotarget.28023. eCollection 2021 Aug 17.
- Background: PubMed 18502105Haviland JS, Ashton A, Broad B, Gothard L, Owen JR, Tait D, Sydenham MA, Yarnold JR, Bliss JM. Evaluation of a method for grading late photographic change in breast appearance after radiotherapy for early breast cancer. Clin Oncol (R Coll Radiol). 2008 Sep;20(7):497-501. doi: 10.1016/j.clon.2008.03.017. Epub 2008 May 27.
- Background: PubMed 110740Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979 Feb;5(2):257-61. doi: 10.1016/0360-3016(79)90729-6. 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.
Cynthia Aristei, MD principal investigator
Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Breast Cancer, run by University Of Perugia at 1 site in Italy.
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 7 inclusion and 6 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 19 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 Italy. 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 Cynthia Aristei, MD (+390755783254, cynthia.aristei@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute toxicity (time frame: 1-6 months after RT). The study lists 2 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 NCT05586256, which also lists 3 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 19 Oct 2022.