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Breast NeoplasmsPhase 2NCT01965483

Phase 2 Study of Adjuvant Radiotherapy in Breast Cancer Using a Once a Week Hypofractionated Regimen

A Phase 2 study testing once-weekly breast irradiation in people with Breast Neoplasms, run by Instituto do Cancer do Ceara at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
once-weekly breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteBrazil
Study dates
Nov 2013to Jun 2016
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 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Radiotherapy Department, Instituto do Cancer do Ceara

    Fortaleza, Ceará, 60430-230

Other trials in Brazil

About this study

Official title: Weekly Hypofractionated Radiotherapy in Breast Cancer: a Phase 2 Clinical Trial

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.

Read the detailed description

The patients will be told about the study and have all their questions clarified. After agreeing to participate in the study they must sign a declaration of free and informed consent.

All the radiation treatments will be carried out in the Radiotherapy Department of the Haroldo Juacaba Hospital. The primary intention of the radiotherapy (RT) is to treat the entire breast. Initially, with the patient in supine position and the making of an individual immobilization device, it will be done a pre-planning in a conventional radiotherapy simulator. After that, a CT-scan will be performed for the three-dimensional conformal radiation planning.

The contouring of the treatments volumes (target volumes and organs-at-risk) and the dosimetric calculations will be performed in the Eclipse treatment planning system (Varian Medical Systems, Palo Alto-CA, USA). The total dose prescribed will be of 30 Gy, in 5 fractions of 6.0 Gy, 1 fraction per week, 1 week apart in the same weekday. In the dosimetric analysis, at least 95% of the breast target-volume must be covered by ≥ 95% of the prescription dose. The point of maximum dose must be less than 110%.

Clinical evaluations will be carried out weekly during the treatment course and in the 4th and 8th weeks after the conclusion of RT. The toxicity will be graduated according to the Common Toxicity Criteria for Adverse Events (CTCAE), v 3.0.

Breast photographs will be held initially and 6 and 12 months after treatment. Breast cosmetic appearance will evaluated by 2 radiation oncologists and classified according to the Harvard scale. The patient's self-referred quality-of-life (QoL) data will be collected in 3 different moments, before the begging of RT just at the end and 1 month after the conclusion of RT. The QoL evaluation tools to be used are the European Organization for Research and Treatment of Cancer (EORTC) QLQ-30 and the breast cancer specific module QLQ-BR23 questionnaires. The projected sample size is 40 patients.

Which patient has the right of no longer be part of the study at any time, if this will be her desire. The study will be interrupted in the case of severe toxicity (≥ grade IV), death caused by the treatment and/or local recurrence superior than the expected, as the reported by literature. Interim analyzes will be performed every 6 months for better monitoring of these possible outcomes.

Being tested
once-weekly breast irradiation
Keywords
radiotherapy, adjuvant, weekly hypofractionation
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • once-weekly breast irradiationRadiation

Study groups in NCT01965483
Study groupRoleWhat they receive
Weekly radiationExperimentalonce-weekly breast irradiation
Receives: Radiation: once-weekly breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number patients with adverse events

    Measured: RT duration, 5 weeks

Secondary outcomes (5)

  1. Cosmetic appearance

    Measured: One year

  2. Number of local failures after RT

    Measured: One year

  3. Cancer specific survival

    Measured: One year

  4. Quality-of-life

    Measured: one month

  5. Adherence to RT regimen

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionOct 2015
  4. Study completionJun 2016

Resources

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
Non-randomised
Intervention model
Single group
Model description
ONCE-WEEKLY HYPOFRACTIONATED RADIOTHERAPY FOR BREAST CANCER: PHASE II NON-RANDOMIZED CLINICAL TRIAL
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01965483
Sponsor's protocol ID
009/2013
Status last verified
Nov 2017
First submitted
13 Oct 2013
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21752481

  • 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.

    PubMed 23195779

  • 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.

    PubMed 19168297

  • 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.

    PubMed 31165541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing once-weekly breast irradiation in people with Breast Neoplasms, run by Instituto do Cancer do Ceara at 1 site in Brazil.

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 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: finished, as of the sponsor's last update on 17 Nov 2017. 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number patients with adverse events (time frame: RT duration, 5 weeks). 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 NCT01965483, which also lists 4 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 17 Nov 2017.

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