Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery (LAPIDARY)
4 maart 2021 bijgewerkt door: Eduardo Barbieri, Instituto Brasileiro de Controle do Cancer
Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.
There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
Studie Overzicht
Toestand
Werving
Conditie
Gedetailleerde beschrijving
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.
Studietype
Ingrijpend
Inschrijving (Verwacht)
36
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Eduardo Barbieri
- Telefoonnummer: +551198639-1945
- E-mail: edurxt@gmail.com
Studie Contact Back-up
- Naam: Alayne D Yamada, PhD
- Telefoonnummer: +55113474-4242
- E-mail: alayne.pesquisa@ibcc-mooca.org.br
Studie Locaties
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SP
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Sao Paulo, SP, Brazilië, 03102-002
- Werving
- IBCC Oncologia
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Contact:
- Eduardo Barbieri
- Telefoonnummer: +55 11 98639-1945
- E-mail: edurxt@gmail.com
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Hoofdonderzoeker:
- Eduardo Barbieri
-
Contact:
- Alayne D Yamada, PhD
- Telefoonnummer: +55113474-4242
- E-mail: alayne.pesquisa@ibcc-mooca.org.br
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Information to the patient and signed informed consent;
- Women aged ≥50 years
- Breast conserving surgery
- Pathologic tumor size < 3 cm (maximum microscopic diameter of the invasive component)
- Invasive adenocarcinoma (except classic invasive lobular carcinoma)
- Unifocal disease
- Histopathologic grades I or II
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Lymphovascular invasion absent
- Negative axillary lymph nodes
- Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
- No prior breast or mediastinal radiotherapy
- No hematogenous metastases
Exclusion Criteria:
- Previous malignancy (except non-melanomatous skin cancer)
- Mastectomy
- Classical-Type Invasive Lobular Carcinoma
- Neoadjuvant chemotherapy
- Human Epidermal growth factor Receptor-type 2 positive (HER2+)
- Triple-negative breast cancers
- Intravascular lymphoma present
- Contraindications to radiotherapy.
- No geographical, social or psychologic reasons that would prevent study follow
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Active Comparator: Standard
Whole breast Radiotherapy, 40 Gray (40Gy) fractions
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Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
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Experimenteel: Experimental 1: Hypofractionated radiotherapy
Whole breast Radiotherapy, 26 Gray (26Gy) in 5 fractions
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Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
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Experimenteel: Experimental 2: Accelerated Partial Breast Irradiation
Partial Breast Irradiation 26 Gray (26Gy) to the tumor bed in 5 fractions.
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Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of local recurrence
Tijdsspanne: 5 years
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To estimate and compare the rate of local recurrence between the experimental and control arms.
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5 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Time to occurrence of distant metastases
Tijdsspanne: 5 years
|
Distant tumor time is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up.
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5 years
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Disease-free survival
Tijdsspanne: 5 years
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Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.
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5 years
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Overall survival
Tijdsspanne: 5 years
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Overall survival time, defined as number of days from randomization until death or end of follow-up.
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5 years
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Medico-economic study
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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To evaluate and compared the cost between Accelerated Partial Breast Irradiation with Standard and Hypofractionated irradiation
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Health-related Quality of Life
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patients quality of life with the help of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
This questionnaire was designed to be cancer specific, multidimensional in structure, suitable for self-administration (brief and easy to complete), and applicable in a wide range of cultural contexts.
The scores in each dimension are uniformly transformed to dimensions ranging from 0 to 100, with 0 denoting the negative (low functioning, high symptom burden) and 100 the positive end (high functioning, low symptom burden) of the continuum.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life with the help of the European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23).
The 23-item EORTC QLQ BR23 contains two breast cancer specific functional scales (body image and sexuality) and three symptom scales evaluating arm symptoms, breast symptoms, and systemic therapy symptoms.
The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life with the help of the Functional Assessment of Cancer Therapy-Fatigue (FACT-F).
Scores are interpreted according to the guidelines of the Scoring Manual.
The higher the number of points, the better the quality of life.
To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Measurement Satisfaction of Body Image of the participants
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life and patient satisfaction with the help of the Body Image Scale (BIS).
Scores are interpreted according to the guidelines of the Scoring Manual.
The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment.
The total score ranges from 0 to 30.
A higher score means a higher level of body image disturbance.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Changes in anxiety and depression
Tijdsspanne: Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
|
To evaluate the patient quality of life and patient satisfaction with the help of the Hospital Anxiety and Depression Scale (HADS).
Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21.
Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
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Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end
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Early and late adverse effects in normal tissues
Tijdsspanne: 5 years
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To evaluate the results reported by patient and evaluated by doctors, as well as, photographic assessments.
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5 years
|
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Late adverse effects
Tijdsspanne: 5 years
|
To evaluate if the patient had symptoms of swelling or edema in the arm, breast shrinkage, hardness, pigmentation, necrosis, pain and tenderness in the breast.
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5 years
|
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Acute toxicity rate
Tijdsspanne: 5 years
|
To evaluate acute toxicity rate.
The maximum grade for acute toxicity will be recorded for each patient at each treatment evaluation using Common Terminology Criteria for Adverse Events.
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5 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, Saieva C, Paiar F, Scotti V, De Luca Cardillo C, Bastiani P, Orzalesi L, Casella D, Sanchez L, Nori J, Fambrini M, Bianchi S. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole breast irradiation: 5-year survival analysis of a phase 3 randomised controlled trial. Eur J Cancer. 2015 Mar;51(4):451-463. doi: 10.1016/j.ejca.2014.12.013. Epub 2015 Jan 17.
- Veronesi U, Orecchia R, Maisonneuve P, Viale G, Rotmensz N, Sangalli C, Luini A, Veronesi P, Galimberti V, Zurrida S, Leonardi MC, Lazzari R, Cattani F, Gentilini O, Intra M, Caldarella P, Ballardini B. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomised controlled equivalence trial. Lancet Oncol. 2013 Dec;14(13):1269-77. doi: 10.1016/S1470-2045(13)70497-2. Epub 2013 Nov 11.
- Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.
- Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
- Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
- Polgar C, Fodor J, Major T, Sulyok Z, Kasler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013 Aug;108(2):197-202. doi: 10.1016/j.radonc.2013.05.008. Epub 2013 Jun 3.
- Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
- Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.
- Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2017 Sep 9;390(10099):1048-1060. doi: 10.1016/S0140-6736(17)31145-5. Epub 2017 Aug 2.
- Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.
- Imielinski K. [Sexuality and personality]. Ginekol Pol. 1981 Mar;52(3):293-7. No abstract available. Polish.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 maart 2021
Primaire voltooiing (Verwacht)
7 december 2025
Studie voltooiing (Verwacht)
31 december 2026
Studieregistratiedata
Eerst ingediend
4 december 2020
Eerst ingediend dat voldeed aan de QC-criteria
9 december 2020
Eerst geplaatst (Werkelijk)
17 december 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 maart 2021
Laatste update ingediend die voldeed aan QC-criteria
4 maart 2021
Laatst geverifieerd
1 november 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 38341220.8.0000.0072
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
The findings will be shared and discussed with all investigators in the study.
A study manuscript, having received contributions from all authors, will be submitted for publication in scientific circles.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .