Ultra-hypofractionated Radiotherapy in Breast Cancer Patients

Female Breast Cancer Clinical Trial

Official title:

Ultra-hypofractionated Adjuvant Radiotherapy After Breast Conserving Surgery in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586256
• Other study ID #: FAST-F-PG01
• Status: Recruiting
• Start date: July 21, 2021
• Est. completion date: July 21, 2026

Study information

• Verified date: October 2022
• Source: University Of Perugia
• Contact: Cynthia Aristei, MD
• Phone: +390755783254
• Email: cynthia.aristei[@]unipg.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 21, 2026
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Female Breast Cancer

Intervention

Radiation:
• ultra-hypofractionated whole breast irradiation
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.

Locations

Country	Name	City	State
Italy	Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Harris 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. — View Citation

Haviland 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-6 months after RT
Primary	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	from 6 months after RT to 60 months
Secondary	overall survival	overall survival	1 month after RT and then every 4-6 months for 5 years
Secondary	disease-free survival	disease-free survival	1 month after RT and then every 4-6 months for 5 years
Secondary	rates of local and loco-regional recurrence	rates of local and loco-regional recurrence	1 month after RT and then every 4-6 months for 5 years
Secondary	distant metastasis occurence	distant metastasis occurence	1 month after RT and then every 4-6 months for 5 years
Secondary	cosmetic outcome	Breast cosmetic result will be graded according to Harvard scale of breast cosmesis (1. Excellent - 2. Good - 3. Fair - 4. Poor)	at baseline and then after 6 months and then 1, 2 and 5 years
Secondary	QoL assessment	EORTC QLQ-C30	at baseline and then after 6 months and then 1, 2 and 5 years
Secondary	QoL assessment	EORTC-QLQ-BR23	at baseline and then after 6 months and then 1, 2 and 5 years
Secondary	photographic assessment	consensus scoring method described by Haviland et al.	at baseline and then after 6 months and then 1, 2 and 5 years