- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04947280
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
23. juni 2021 opdateret af: Fudan University
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Eligible breast cancer patients with bone metastases will be treated with FSRT.
9-10 Gy x 3Fx or 6-7 Gy x 5Fx image-guided fractionated stereotatic radiation therapy will be used.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zhaozhi Yang, MD, Ph.D
- Telefonnummer: 8618017317126
- E-mail: yzzhi2006@yahoo.com.cn
Undersøgelse Kontakt Backup
- Navn: Wei Shi, MD, Ph.D
- Telefonnummer: 8618121299680
- E-mail: wei.shi118@foxmail.com
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Diagnosis of invasive breast cancer
- Signed informed consent
- Bone metastases (confirmed by MRI within 4 weeks of enrollment).
- Paraosseous soft tissue ≤ 5cm. The tumour could involve the vertebral column, but did not have to, nor did it need to enter the spinal canal.
- KPS ≥ 40 or ECOG 0-2.
- The tumor is at least 2 mm away from the spinal cord. If the tumor is closer than 2 mm, surgical resection is required prior to FSRT or the total prescription dose of spinal cord is strictly limited.
- Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, and refusal to undergo surgery.
- A maximum of three distinct noncontiguous spinal metastases per patient was allowed, and each of the separate sites may have involvement of 2 contiguous vertebral bodies.
- Patients have sufficient bone marrow reserve and liver and kidney function: neutrophil count ≥ 1500 cells / mm3; platelet count ≥ 70000 / mm3; hemoglobin (Hgb) ≥ 8.0 g / dl; if there is liver metastasis, AST and ALT < 3x ULN
- The interval between systemic chemotherapy is more than 2 weeks, and the side effects recovery from previous treatment ≤ grade 1
- Patients receiving bisphosphonates, endocrine or targeted therapy at the same time were not included
Exclusion Criteria:
- Patients with mechanically unstable spine or epidural spinal cord compression were excluded; however, patients with previously documented spinal cord compression that had been decompressed and stabilized were eligible. Patients with > 50% loss of vertebral body height were excluded.
- Patients in whom a delay in initiating treatment might have adversely affected neurological outcome.
- Patients with a pacemaker, unable to undergo MR imaging and unable to lie flat for at least 30 minutes.
- Patients who had a history of previous radiotherapy to the spine at the current level of interest.
- Patients who had received prior external-beam irradiation to the spine within 3 months of registration.
- Patients who had received systemic radiotherapy (Strontium-89) within 30 days of starting protocol treatment.
- Patients who had received chemotherapy within 2 weeks of starting protocol treatment.
- Patients who are unwilling or unable to receive regular follow-up.
- The patients judged by the researchers who could not be included in some special cases.
- Serious complications: cardiovascular disease, end-stage renal disease, serious liver disease, infection, et al.
- Pregnant women.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Fractionated Stereotatic Radiation Therapy
|
Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Local Control Rate
Tidsramme: 3 years
|
Determine the local control rate of FSRT in patients with bone metastasis of breast cancer
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain Control
Tidsramme: 3 years
|
Evaluate whether FSRT improves pain control as measured by Brief Pain Inventory (BPI) after FSRT in patients with spinal metastasis of breast cancer
|
3 years
|
Overall Survival
Tidsramme: 3 years
|
Time from the date of informed consent until to the date of death, regardless of the cause of death
|
3 years
|
Progression Free Survival
Tidsramme: 3 years
|
Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first
|
3 years
|
Quality of Life
Tidsramme: 3 years
|
Evaluate the quality of life according to EORTC QLQ-BM22
|
3 years
|
Vertebral Fracture and Radiation Myelitis
Tidsramme: 3 years
|
Determine the incidence of bone fracture and radiation myelitis
|
3 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Zhaozhi Yang, MD, Ph.D, Fudan University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2021
Primær færdiggørelse (Forventet)
31. december 2025
Studieafslutning (Forventet)
31. december 2026
Datoer for studieregistrering
Først indsendt
8. april 2021
Først indsendt, der opfyldte QC-kriterier
23. juni 2021
Først opslået (Faktiske)
1. juli 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FDRT-BC012
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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