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Stereotaktische Körperbestrahlung (SBRT) zur frühen Behandlung des oligometastatischen adenoiden zystischen Karzinoms: Die SOLAR-Studie

30. September 2026 aktualisiert von: Jonathan Schoenfeld, MD, MPH, Dana-Farber Cancer Institute

The aim of this study is to learn whether the early initiation of a specialized and focused type of radiation called stereotactic body radiation therapy (SBRT) will impact the progression of advanced adenoid cystic carcinoma, quality of life, and overall survival.

The name(s) of the study intervention involved in this study is:

  • Stereotactic Body Radiation Therapy (SBRT)

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is a randomized phase II, open-label and non-blinded two-arm study aimed to investigate the potential benefit of treating oligometastatic adenoid cystic carcinoma (ACC) with early initiation of stereotactic body radiotherapy (SBRT). Given the overall uncertainty about the role of local therapy in the treatment of ACC, there is also a prospective observational cohort that will investigate outcomes following local ablative treatments in patients with advanced or metastatic ACC.

This research study is investigating how the specialized and focused stereotactic body radiation therapy (SBRT) impacts disease progression, quality of life, and overall survival in patients with a limited number of metastases (one to five) from their adenoid cystic carcinoma cancer. The use of SBRT to treat all areas of disease after early spread of ACC is investigational. SBRT is a more focused form of radiation compared to the palliative radiation typically received per standard of care treatment. Recent retrospective studies conducted suggest that patients with adenoid cystic carcinoma cancer may benefit from early initiation of a targeted radiation therapy.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. After enrollment participants will be randomized into two groups: Standard of Care or Stereotactic body radiotherapy (SBRT). All participants in the study, regardless of treatment regimen, will be followed for up to 10 years.

It is expected that about 32 people will take part in this research study.

Two organizations, Gateway for Cancer Research and the Adenoid Cystic Carcinoma Research Foundation (ACCRF), are supporting this research study by providing funding.

Studientyp

Interventionell

Einschreibung (Geschätzt)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94158
        • Rekrutierung
        • University of California, San Francisco
        • Kontakt:
        • Hauptermittler:
          • Sue Yom, MD, PhD
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • Rekrutierung
        • University of Chicago
        • Hauptermittler:
          • Alexander T Pearson, MD, PhD
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02115
        • Rekrutierung
        • Brigham and Women's Hospital
        • Hauptermittler:
          • Jonathan D Schoenfeld, MD, MPH
        • Kontakt:
      • Boston, Massachusetts, Vereinigte Staaten, 02215
        • Rekrutierung
        • Dana Farber Cancer Institute
        • Kontakt:
        • Hauptermittler:
          • Jonathan D Schoenfeld, MD, MPH
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Rekrutierung
        • MD Anderson Cancer Center
        • Kontakt:
        • Hauptermittler:
          • Matthew S Ning, MD, MPH

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on imaging (biopsy of metastatic disease preferred, but not required)

  • Cohort 1

    • One to five detectable sites of metastatic disease at any organ or site (including bone and CNS involvement)

      • Maximum size of 3 cm for brain lesions.
      • Note: Measurable disease is not required
      • Note: Patients with isolated intracranial disease for whom SRS would be the preferred standard of care are not eligible.
      • Note: Patients may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3 months as determined by the investigator

  • Cohort 2

    • At least 1 site of non-osseous disease

  • Cohort 1

    • All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose / dose constraints (there is no prespecified minimum or maximum size)

  • Cohort 2

    • At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization

  • Cohort 1

    • Primary tumor either controlled, or amenable for local treatment with SBRT
    • Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment

  • Age 18 years or older

  • ECOG performance status of 0-2

  • Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT.

  • Cohort 1

    • For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation):

      • If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site
      • If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT

  • Ability to understand and the willingness to sign a written informed consent document.

  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy.

"Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.

  • Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.

Exclusion Criteria:

  • Cohort 1

    • Subject who has received systemic therapy for treatment of ACC within 2 weeks of enrollment.

  • Evidence of need for urgent surgical intervention for metastatic CNS or spine disease.

  • Cohort 1

    • Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or [chemo]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of SBRT.

  • Bone metastasis in a femoral bone for which surgical stabilization is recommended.

  • Cohort 1

    • Active disease >1 cm that is progressing and not amenable to SBRT.

  • Pregnant or lactating women.

  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard of Care (Cohort 1)

Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).
Sonstiges: Standard of Care

Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).
Experimental: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)

Participants will be randomly assigned and receive SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer.

After SBRT is completed participant may go on to receive systemic therapy (like chemotherapy, immunotherapy, or targeted therapies) per discretion of their treating physician.
Strahlung: SBRT

SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer

Andere Namen:
  • Stereotaktische Körperbestrahlung
Kein Eingriff: Local Ablative Therapy (Cohort 2)

Participants embarking on standard of care local ablative therapy (not limited to radiofrequency, microwave, or cryoablation, bland or chemoembolization, palliative radiotherapy, or surgical metastasectomy) not eligible for cohort 1 will be enrolled and followed.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression Free Survival (PFS) (Cohort 1)
Zeitfenster: Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years

Assessed using RECIST v1.1 and Kaplan-Meier
Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years
Local Control Rate (Cohort 2)
Zeitfenster: 2 years from enrollment

Estimating 2-year local control rate following local treatment of ACC lesions. Assessed using RECIST v1.1.
2 years from enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS)
Zeitfenster: Time from randomization to death from any cause or date last known alive, assessed up to 5 years

Assessed using RECIST v1.1 and Kaplan-Meier
Time from randomization to death from any cause or date last known alive, assessed up to 5 years
Toxicity Rate
Zeitfenster: Enrollment to end of treatment up to 2 years

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Enrollment to end of treatment up to 2 years
Quality of Life (QOL) assessments by FACT-G
Zeitfenster: Baseline and every 3 months for 2 years

Descriptive statistics will be performed to characterize QOL data
Baseline and every 3 months for 2 years
Local Disease Control Rate
Zeitfenster: Time from randomization to free of locoregional progression, assessed up to 5 years

Free of locoregional progression within irradiated oligometastatic sites, assessed using Kaplan-Meier
Time from randomization to free of locoregional progression, assessed up to 5 years
Time to next systemic therapy for progression of disease
Zeitfenster: Time from randomization to initiation of systemic therapy for progression of disease, assessed up to 5 years

Assessed using Kaplan-Meier
Time from randomization to initiation of systemic therapy for progression of disease, assessed up to 5 years
Time to local therapy for progression of disease
Zeitfenster: Time from randomization to initiation of local therapy for progression of disease, assessed up to 5 years

Assessed using Kaplan-Meier
Time from randomization to initiation of local therapy for progression of disease, assessed up to 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Dana-Farber Cancer Institute

Mitarbeiter

Adenoid Cystic Carcinoma Research Foundation
Gateway for Cancer Research

Ermittler

  • Hauptermittler: Jonathan D Schoenfeld, MD, MPH, Brigham and Women's Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Dezember 2021

Primärer Abschluss (Geschätzt)

1. Juni 2028

Studienabschluss (Geschätzt)

1. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

3. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2021

Zuerst gepostet (Tatsächlich)

12. Mai 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 21-171

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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