Ultra-hypofractionated Radiotherapy in Breast Cancer Patients

NCT05586256 | Recruiting DMC

• 1 other identifier: FAST-F-PG01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Female Breast Cancer

Keywords

early stage breast cancer; breast conserving surgery; ultra-hypofractionated whole breast irradiation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• overall survival

  1 month after RT and then every 4-6 months for 5 years

• disease-free survival

  1 month after RT and then every 4-6 months for 5 years

• rates of local and loco-regional recurrence

  1 month after RT and then every 4-6 months for 5 years

• distant metastasis occurence

  1 month after RT and then every 4-6 months for 5 years

• cosmetic outcome

  at baseline and then after 6 months and then 1, 2 and 5 years

Interventions

ultra-hypofractionated whole breast irradiation RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Age\<18 years.
• Regional nodal radiotherapy.
• Distant metastases.
• 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.

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia

Perugia, 06132, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 34434502 BACKGROUND

• 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.

  PMID: 18502105 BACKGROUND

• 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. doi: 10.1016/0360-3016(79)90729-6. No abstract available.

  PMID: 110740 BACKGROUND

Study Officials

• Cynthia Aristei, MD

  Radiation Oncology Section, Department of Medicine and Surgery, University of Perugia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Aristei, MD

CONTACT

+390755783254; cynthia.aristei@unipg.it

Isabella Palumbo, MD

CONTACT

+390755783254; isabella.palumbo@unipg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 19, 2022
• Study Start: July 21, 2021
• Primary Completion: July 21, 2023
• Study Completion (Estimated): July 21, 2026
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)