올리고 전이성 유방암에 대한 정위 절제 방사선 요법 (TAORMINA)
희소 전이성 유방암의 치료 - 1차 치료제로 전신 치료 단독으로 정위 절제 방사선 요법과 전신 치료를 비교하는 무작위 3상 시험
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
연구 개요
상세 설명
TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.
Patients with 1-5 metastases in 1-2 organs (confirmed by PET-CT) with any breast cancer subtype can be enrolled. All metastases must be available for SABR.
The primary aim is to investigate if the addition of SABR to the oligometastatic sites in addition to the standard first-line treatment can improve progression-free survival (PFS).
Secondary aims are to compare overall survival (OS), response rate and time to development of new lesions, acute and late toxicity. quality of life, time to start of chemotherapy (luminal patients).
Exploratory analyses:
Circulating tumour DNA as an early sign of disease progression. Immun panel for determination of the effect of SABR on patients´ immune response.
To investigate the survival for each BC subtype (Luminal, HER2+ and TNBC). To investigate survival in patients with de novo OMBC and recurrent OMBC respectively.
Stratifications are based on subtype (luminal, HER2-positive vs TNBC) and type of OMBC (de novo vs. recurrent) without formal sample size calculation for the stratification factor (exploratory analysis).
Patients with de novo metastatic OMBC that is planned for neoadjuvant treatment are recommended to complete treatment followed by standard surgery and radiotherapy or SABR towards the primary tumour lesion(s).
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Katarzyna Kulbacka-Ortiz, CTO
- 전화번호: +46721470685
- 이메일: katarzyna.kulbacka-ortiz@vgregion.se
연구 연락처 백업
- 이름: Annika Baan
- 전화번호: +46700906097
- 이메일: annika.baan@vgregion.se
연구 장소
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Bergen, 노르웨이, 5021
- 모병
- Haukeland University Hospital
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연락하다:
- Vidhi Shukla, MD
- 전화번호: +47 55 97 50 00
- 이메일: vidi.shukla@helse-bergen.no
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수석 연구원:
- Vidhi Shukla, MD
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Oslo, 노르웨이, 0424
- 모병
- Oslo University Hospital, Radiumhospitalet
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연락하다:
- Veronica Feilum
- 전화번호: +47-942244
- 이메일: uxfeve@ous-hf.no
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연락하다:
- Maria Elena Rodriguez Aguillar
- 이메일: maerod@ous-hf.no
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수석 연구원:
- Vidar Gordon Flote, MD, PhD
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Tromsø, 노르웨이, 9019
- 모병
- Universitetssykehuset Nord-Norge
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연락하다:
- Kristin Iren Jensen
- 전화번호: + 47 77 66 92 12
- 이메일: Kristin.Iren.Jensen@unn.no
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연락하다:
- Maria Therese Danielsen
- 이메일: maria.theres.danielsen@unn.no
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수석 연구원:
- Hanna Stromholt Bremnes, MD
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Trondheim, 노르웨이, 7006
- 모병
- St. Olavs Hospital
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연락하다:
- Kjerstin Olaussen
- 전화번호: +47-72825782
- 이메일: Kjerstin.Olaussen@stolav.no
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연락하다:
- Britt Torun Fjær Nydal
- 이메일: Britt.Torunn.Fjer.Nydal@stolav.no
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수석 연구원:
- Solveig Hoff
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Region Jönköpings Län
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Jönköping, Region Jönköpings Län, 스웨덴, 551 85
- 모병
- Ryhov County Hospital
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수석 연구원:
- Maria Ekholm, MD, PhD
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연락하다:
- Therese Karlsson, Study nurse
- 전화번호: +46 10-242 59 62
- 이메일: therese.i.karlsson@rjl.se
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Region Skåne
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Malmö, Region Skåne, 스웨덴
- 모병
- Skånes University Hospital
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연락하다:
- Charlotta Wollheim, Study nurse
- 전화번호: +46 40 337461
- 이메일: charlotta.wollheim@skane.se
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수석 연구원:
- Muhammad Kadum, MD
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Region Stockholm
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Stockholm, Region Stockholm, 스웨덴, 17176
- 모병
- Karolinska University Hospital
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연락하다:
- Karin Hedgren, Study nurse
- 전화번호: +46-8-123 71746
- 이메일: karin.hedgren@regionstockholm.se
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수석 연구원:
- Caroline Boman, MD
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Region Västerbotten
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Umeå, Region Västerbotten, 스웨덴, 901 85
- 모병
- Norrlands University Hospital
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연락하다:
- Dmitry Domkin, Study nurse
- 전화번호: +46 90-785 35 95
- 이메일: dmitry.domkin@regionvasterbotten.se
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연락하다:
- Jeanette Johansson, Study nurse
- 전화번호: +46-90-785 06 89
- 이메일: jeanette.johansson@regionvasterbotten.se
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수석 연구원:
- Kristina Weibring, MD, PhD
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Region Örebro Län
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Örebro, Region Örebro Län, 스웨덴, SE-701 85
- 모병
- Örebro University Hospital
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연락하다:
- Emma Nordh, Study nurse
- 전화번호: +46 19 602 27 19
- 이메일: emma.nordh@regionorebrolan.se
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연락하다:
- Jenny Larsson, Study nurse
- 전화번호: +46-31-3426791
- 이메일: jenny.larsson4@regionorebrolan.se
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수석 연구원:
- Eva Tegnelius, MD
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Västra Götalandsregionen
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Gothenburg, Västra Götalandsregionen, 스웨덴, 41345
- 모병
- Sahlgrenska University Hospital
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연락하다:
- Katarzyna Kulbacka, Head CTO
- 이메일: katarzyna.kulbacka-ortiz@vgregion.se
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연락하다:
- Mitra Sharifi Jahanfard, Study nurse
- 전화번호: +46-31-3426791
- 이메일: mitra.sharifi-jahanfard@vgregion.se
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Ljubljana, 슬로베니아, 1000
- 모병
- Institute of Oncology Ljubljana
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연락하다:
- Minka Macanovic
- 전화번호: +386 (0)1 58 79 550
- 이메일: mmacanovic@onko-i.si
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연락하다:
- Erika Primc
- 이메일: eprimc@onko-i.si
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수석 연구원:
- Ivica Ratoša, MD
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Cork, 아일랜드, T12 DC4A
- 모병
- Cork University Hospital
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연락하다:
- Ella O'Sullivan, MD
- 전화번호: +353 (0) 21 4922000
- 이메일: ella.osullivan@hse.ie
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수석 연구원:
- Aisling Barry, Prof.
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Cork, 아일랜드, T12 DV56
- 모병
- Bon Secours Cork In Partnership with UPMC Hillman Cancer Centre
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연락하다:
- Karen Molan, MD
- 전화번호: +353 (0)21-486 1100
- 이메일: molank@upmc.ie
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수석 연구원:
- Kathy Rock, MD
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Dublin, 아일랜드
- 모병
- St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital Dublin, St James Hospital Dublin and Beaumont Hospital Dublin
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연락하다:
- Vitor Oliviera
- 전화번호: +353 (0) -1-420 6900
- 이메일: Vitor.Oliveira@slh.ie
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수석 연구원:
- Frances Duane, Prof.
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Galway, 아일랜드, H91 YR71
- 모병
- University Hospital Galway (UHG)
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연락하다:
- Laura Nally
- 전화번호: +353 91 54 2785
- 이메일: laura.nally@hse.ie
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수석 연구원:
- Ronan McDermott, MD
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Tel Aviv, 이스라엘, 5265601
- 모병
- Sheba Medical Center Institute of Oncology
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연락하다:
- Aliza Ackerstein
- 전화번호: +972-3-5302542
- 이메일: aliza.ackerstein@sheba.health.gov.il
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연락하다:
- Chen Gross
- 이메일: Chen.Gross@sheba.health.gov.il
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수석 연구원:
- Einav Nili Gal-Yam, MD
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Florence, 이탈리아, 3 50134
- 모병
- Azienda Ospedaliero - Universitaria Careggi
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연락하다:
- Michela Carracino
- 전화번호: +390552751828
- 이메일: carracinom@aou-careggi.toscana.it
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수석 연구원:
- Icro Meattini, Prof.
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Milan, 이탈리아
- 모병
- Humanitas Cancer Centre
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연락하다:
- Marta Scorsetti, MD, PhD
- 전화번호: +39 02 8224 8524
- 이메일: marta.scorsetti@hunimed.eu
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수석 연구원:
- Marta Scorsetti, Prof.
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Milan, 이탈리아
- 모병
- Istituto Nationale Tumori (INT)
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연락하다:
- Maria Carmen De Santis, MD
- 전화번호: +39-0223903280
- 이메일: mariacarmen.desantis@istitutotumori.mi.it
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수석 연구원:
- Maria Carmen De Santis, Prof.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Histologically or cytological confirmed recurrent OMBC.
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Age ≥18 years old.
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OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.
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Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.
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Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.
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Patients with local recurrence and OMBC must have a controlled local recurrence.
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ECOG/WHO 0-2.
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Life expectancy > 6 months.
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Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).
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Symptomatic bone metastases are allowed if ablative therapy can be delivered.
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Adequate organ function for the planned treatment according to local guide-lines.
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For patients with liver metastasis:
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No cirrhosis or hepatitis
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Hepatic function:
- Total bilirubin level < 3.0 x institutional ULN
- ALT, AST, GGT, and alkaline phosphatase levels < 3.0 x institutional ULN
- Albumin > 2.5 mg/dL
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Metastasis not adjutant to stomach or small bowel.
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For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of > 60mL/min.
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Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.
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Negative pregnancy test within 14 days prior to start of treatment*.
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If childbearing potential, willing to use an effective form of contraception*.
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No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
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Signed informed consent and willingness to follow the trial procedures.
Exclusion Criteria:
- > 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included). Change due to toxicity allowed.
- Oligometastases in brain.
- Malignant pleural effusion or ascites.
- Metastasis growth that involves > 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit.
- Unable to undergo imaging by either CT scan or MRI.
- Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
- Pregnancy or breast-feeding.
- Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental SABR arm
Standard first line systemic therapy + SABR. |
Stereotactic Ablative Radiotherapy is delivered to all metastatic lesions. |
|
간섭 없음: Control systemic therapy arm
Standard first line systemic therapy. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free survival (PFS)
기간: 3 years after the last patient inclusion
|
Time from the date of randomisation to the date of disease-progression at any site or death from any cause. |
3 years after the last patient inclusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival (OS)
기간: 3 years after the last patient inclusion
|
Time from the date of randomisation to the date of death from any cause. |
3 years after the last patient inclusion
|
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Local Control Rate (LCR)
기간: 3 years after the last patient inclusion
|
Time from the date of randomisation to the date of progress in previously treated metastases |
3 years after the last patient inclusion
|
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Safety analysis - acute toxicity
기간: From the first dose of SABR to 3 months after the last dose of SABR
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Reported according to CTCAE v.5.0 |
From the first dose of SABR to 3 months after the last dose of SABR
|
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Safety analysis - late toxicity
기간: From the first dose of SABR to 3 years after the last dose of SABR
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Reported according to CTCAE v.5.0 |
From the first dose of SABR to 3 years after the last dose of SABR
|
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Health-related quality of life Cancer-30
기간: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
|
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaires Cancer-30 (EORTC-QLQ C30) |
At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
|
|
Health-related quality of life Breast-23
기간: At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
|
European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Breast-23 (EORTC-QLQ B23) |
At base-line and after 3, 6, 9, 12, 18, 24 and 36 months after registration.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Barbro K Linderholm, MD, PhD, Sahlgrenska University Hospital, Gothenburg
간행물 및 유용한 링크
일반 간행물
- Milano MT, Katz AW, Zhang H, Okunieff P. Oligometastases treated with stereotactic body radiotherapy: long-term follow-up of prospective study. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):878-86. doi: 10.1016/j.ijrobp.2011.08.036. Epub 2011 Dec 13.
- Milano MT, Zhang H, Metcalfe SK, Muhs AG, Okunieff P. Oligometastatic breast cancer treated with curative-intent stereotactic body radiation therapy. Breast Cancer Res Treat. 2009 Jun;115(3):601-8. doi: 10.1007/s10549-008-0157-4. Epub 2008 Aug 22.
- Trovo M, Furlan C, Polesel J, Fiorica F, Arcangeli S, Giaj-Levra N, Alongi F, Del Conte A, Militello L, Muraro E, Martorelli D, Spazzapan S, Berretta M. Radical radiation therapy for oligometastatic breast cancer: Results of a prospective phase II trial. Radiother Oncol. 2018 Jan;126(1):177-180. doi: 10.1016/j.radonc.2017.08.032. Epub 2017 Sep 21.
- Milano MT, Katz AW, Zhang H, Huggins CF, Aujla KS, Okunieff P. Oligometastatic breast cancer treated with hypofractionated stereotactic radiotherapy: Some patients survive longer than a decade. Radiother Oncol. 2019 Feb;131:45-51. doi: 10.1016/j.radonc.2018.11.022. Epub 2018 Dec 28.
- Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.
- Chalkidou A, Macmillan T, Grzeda MT, Peacock J, Summers J, Eddy S, Coker B, Patrick H, Powell H, Berry L, Webster G, Ostler P, Dickinson PD, Hatton MQ, Henry A, Keevil S, Hawkins MA, Slevin N, van As N. Stereotactic ablative body radiotherapy in patients with oligometastatic cancers: a prospective, registry-based, single-arm, observational, evaluation study. Lancet Oncol. 2021 Jan;22(1):98-106. doi: 10.1016/S1470-2045(20)30537-4.
- Scorsetti M, Franceschini D, De Rose F, Comito T, Villa E, Iftode C, Navarria P, D'Agostino GR, Masci G, Torrisi R, Testori A, Tinterri C, Santoro A. Stereotactic body radiation therapy: A promising chance for oligometastatic breast cancer. Breast. 2016 Apr;26:11-7. doi: 10.1016/j.breast.2015.12.002. Epub 2016 Jan 3.
- David S, Tan J, Savas P, Bressel M, Kelly D, Foroudi F, Loi S, Siva S. Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. Breast. 2020 Feb;49:55-62. doi: 10.1016/j.breast.2019.10.016. Epub 2019 Nov 6.
- Li MP, Kelly D, Tan J, Siva S, Kron T, David S. Single-fraction stereotactic ablative body radiotherapy for sternal metastases in oligometastatic breast cancer: Technique and single institution experience. J Med Imaging Radiat Oncol. 2020 Aug;64(4):580-585. doi: 10.1111/1754-9485.13075. Epub 2020 Jun 25.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .