NCT01965483

Brief Summary

The implementation of a weekly hypofractionated radiation could be an advantageous alternative. The convenience of less treatment days could cause a greater adherence, decrease of costs and increase the offer of radiotherapy to major number of patients in underserved areas. The purpose of this study is to determine in women with diagnosis of initial breast cancer undergoing breast-conserving surgery the effects of the adjuvant radiotherapy using a once a week regimen, with 5 fractions in total. The study will analyze the acute toxicity of radiation, the patient's self referred quality of life, the cosmetic breast appearance, as well the oncological safety. It will also be analyzed the viability of this more contracted regimen in our community setting, regarding the patient's adherence to the treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

October 13, 2013

Last Update Submit

November 15, 2017

Conditions

Breast Neoplasms

Keywords

radiotherapyadjuvantweekly hypofractionation

Outcome Measures

Primary Outcomes (1)

  • Number patients with adverse events

    RT duration, 5 weeks

Secondary Outcomes (5)

  • Cosmetic appearance

    One year

  • Number of local failures after RT

    One year

  • Cancer specific survival

    One year

  • Quality-of-life

    one month

  • Adherence to RT regimen

    5 weeks

Study Arms (1)

Weekly radiation

EXPERIMENTAL

once-weekly breast irradiation

Radiation: once-weekly breast irradiation

Interventions

once-weekly breast irradiationRADIATION
Weekly radiation

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast carcinoma
  • Submitted to breast conserving surgery with pos-op free margins status
  • Early stage: pT1-2N0

You may not qualify if:

  • Positive pathological margins
  • Submitted to chemotherapy, either neoadjuvant or adjuvant
  • Previous breast reconstruction
  • Bilateral breast cancer
  • Previous thoracic irradiation
  • Collagen disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiotherapy Department, Instituto do Cancer do Ceara

Fortaleza, Ceará, 60430-230, Brazil

Location

Related Publications (4)

  • FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.

    PMID: 21752481BACKGROUND

  • Dragun AE, Quillo AR, Riley EC, Roberts TL, Hunter AM, Rai SN, Callender GG, Jain D, McMasters KM, Spanos WJ. A phase 2 trial of once-weekly hypofractionated breast irradiation: first report of acute toxicity, feasibility, and patient satisfaction. Int J Radiat Oncol Biol Phys. 2013 Mar 1;85(3):e123-8. doi: 10.1016/j.ijrobp.2012.10.021. Epub 2012 Nov 27.

    PMID: 23195779BACKGROUND

  • Kirova YM, Campana F, Savignoni A, Laki F, Muresan M, Dendale R, Bollet MA, Salmon RJ, Fourquet A; Institut Curie Breast Cancer Study Group. Breast-conserving treatment in the elderly: long-term results of adjuvant hypofractionated and normofractionated radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):76-81. doi: 10.1016/j.ijrobp.2008.11.005. Epub 2009 Jan 23.

    PMID: 19168297BACKGROUND

  • Reboucas LM, Campos CS, D'Amico GM, Lustosa AB, Fregnani JH. Once-weekly hypofractionated radiotherapy for breast cancer: First results of a phase II clinical trial. Breast J. 2019 Sep;25(5):953-957. doi: 10.1111/tbj.13372. Epub 2019 Jun 4.

    PMID: 31165541DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Conceicao Souza, MD, PhD

    Instituto do Cancer do Ceara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: ONCE-WEEKLY HYPOFRACTIONATED RADIOTHERAPY FOR BREAST CANCER: PHASE II NON-RANDOMIZED CLINICAL TRIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2013

First Posted

October 18, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

BR(1)