A Pilot Study of Ultra-High Dose Rate (ConformalFLASH®), for Reirradiation of Carcinoma of the Head and Neck (C-FLASH-01)
17. september 2026 oppdatert av: IBA Proton Therapy, Inc.
This pilot study is designed to evaluate the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) in participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
ConformalFLASH treatment planning and delivery workflows are comparable to those of conventional Stereotactic Body Radiation Therapy (SBRT), a standard approach for re-irradiation in this population.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
C-FLASH-01 is a pilot study evaluating the feasibility of delivering ultra-high dose-rate conformal proton therapy (ConformalFLASH) to participants requiring re-irradiation for head and neck cancer who are not amenable to surgical resection.
Stereotactic Body Radiation Therapy (SBRT) re-irradiation is a standard approach that enables highly conformal dose delivery over a limited number of fractions.
ConformalFLASH is an investigational approach that applies SBRT principles using proton therapy delivered at ultra-high dose rates (≥ 40 Gray Relative Biological Effectiveness (GyRBE)/second), with the potential to reduce normal tissue toxicity while maintaining tumor control.
Participants will undergo treatment planning and delivery consistent with standard SBRT workflows.
Treatment consists of five fractions (8 GyRBE per fraction) delivered over approximately 1.5 to 2 weeks.
The primary objective is to assess the feasibility of delivering conformal proton SBRT at dose rates ≥ 40 GyRBE/second, along with evaluation of acute toxicity.
Secondary objectives include assessment of treatment delivery accuracy, late toxicity, clinical outcomes, and patient-reported quality of life.
Studietype
Intervensjonell
Registrering (Antatt)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sophie Le Bail
- Telefonnummer: +32 470 226 032
- E-post: sophie.lebail@iba-group.com
Studer Kontakt Backup
- Navn: Sofie Gillis
- Telefonnummer: +32 499 985 686
- E-post: sofie.Gillis@iba-group.com
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Rekruttering
- The University of Pennsylvania, Department of Radiation Oncology
-
Hovedetterforsker:
- Alexander Lin, MD
-
Ta kontakt med:
- Ching Lai
- Telefonnummer: 267-250-9244
- E-post: Ching.Lai@pennmedicine.upenn.edu
-
Ta kontakt med:
- Karen Tang
- Telefonnummer: 267-299-9618
- E-post: Karen.Tang1@Pennmedicine.upenn.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Patients must sign an informed consent document that indicates they are aware of the investigational nature of the treatment in this protocol as well as the potential risks and benefits
- Patients ≥ 18 years old
- Patients ineligible for or decline upfront surgical resection
- Histologically confirmed diagnosis of carcinoma of the head and neck
- Prior receipt of at least 45 GyRBE radiotherapy to the head and neck
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or evidence of similar in the electronic medical record
- Life expectancy of more than 12 weeks
- Ability to understand and the willingness to provide written informed consent and to follow the study procedures
Exclusion Criteria:
- Receipt of prior head and neck radiotherapy within the prior 6 months
- Surgical resection of the current disease in the head and neck
- More than 3 areas of disease requiring reirradiation
- Disease focus exceeding 6.5 cm in greatest dimension
- Presence of distant metastatic disease
- Involvement of any of the following structures: skin, carotid artery, or mandible
- Receipt of concurrent chemotherapy during radiotherapy
- Uncontrolled intercurrent illness including medical and psychiatric, and social situations that would limit compliance with study requirements
- Enrolled in any other investigational studies that involve administrations of another cancer therapeutic (such as surgery, chemotherapy, immunotherapy) during RT
- Pregnant and/or breastfeeding
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment Arm
ConformalFLASH irradiation
|
Subjects will be treated with SBRT (8 GyRBE x 5 fractions over 1.5-2 weeks), using pencil-beam scanning proton therapy, delivered at an average dose rate of ≥ 40 GyRBE/second, without chemotherapy.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ConformalFLASH treatment delivery feasibility
Tidsramme: Through treatment completion (within 1 month after last fraction)
|
Delivery of ≥ 95% of the prescribed dose to ≥ 95% of the clinical target volume (CTV) at an average dose rate of ≥ 40 GyRBE/second
|
Through treatment completion (within 1 month after last fraction)
|
|
Acute toxicities
Tidsramme: Up to 3 months after treatment start
|
Incidence of acute toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 6.0
|
Up to 3 months after treatment start
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ConformalFLASH treatment delivery accuracy
Tidsramme: Through treatment completion (within 1 month after last fraction)
|
Dose delivered to the clinical target volume (CTV) and organs at risk (OARs) as well as the average dose rate to the CTV
|
Through treatment completion (within 1 month after last fraction)
|
|
Late toxicities
Tidsramme: Beyond 3 months after start of treatment and up to 5 years
|
Incidence of late toxicity as assessed by CTCAE version 6.0
|
Beyond 3 months after start of treatment and up to 5 years
|
|
Local Control
Tidsramme: 3 months and 1 year
|
Absence of tumor recurrence or progression at the primary radiated disease site following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Regional control
Tidsramme: 3 months and 1 year
|
Absence of tumor recurrence or progression in regional lymph nodes following initiation of study treatment, as assessed by imaging, supplemented by clinical examination and with biopsy confirmation when indicated
|
3 months and 1 year
|
|
Metastasis-free survival
Tidsramme: 3 months and 1 year
|
Time from first treatment to the first occurrence of distant metastatic disease or death from any cause.
|
3 months and 1 year
|
|
Overall survival
Tidsramme: 3 months and 1 year
|
Time from first treatment to death from any cause
|
3 months and 1 year
|
|
Patient-reported quality of life
Tidsramme: Up to 5 years
|
Effect of the treatment on patient-reported quality of life, using the University of Washington Quality of Life Questionnaire (UW-QOL).The UW-QOL consists of domains based upon discrete ordinal responses regarding their past 7 days. Scoring is scaled so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response. The UW-QOL comprises 12 single-question domains, each between 3 and 6 response options. These options are scaled evenly from 0 (worst) to 100 (best), according to the hierarchy of response. Each domain is scored individually, and an overall composite score can be derived. In addition, patients are asked to choose up to 3 of these domains that they consider most important to them. The UW-QOL also includes 3 global questions, one about how patient feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL. |
Up to 5 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alexander Lin, MD, University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Vargo JA, Ferris RL, Ohr J, Clump DA, Davis KS, Duvvuri U, Kim S, Johnson JT, Bauman JE, Gibson MK, Branstetter BF, Heron DE. A prospective phase 2 trial of reirradiation with stereotactic body radiation therapy plus cetuximab in patients with previously irradiated recurrent squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Mar 1;91(3):480-8. doi: 10.1016/j.ijrobp.2014.11.023. Epub 2015 Jan 30.
- Heron DE, Ferris RL, Karamouzis M, Andrade RS, Deeb EL, Burton S, Gooding WE, Branstetter BF, Mountz JM, Johnson JT, Argiris A, Grandis JR, Lai SY. Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1493-500. doi: 10.1016/j.ijrobp.2008.12.075. Epub 2009 May 21.
- Lartigau EF, Tresch E, Thariat J, Graff P, Coche-Dequeant B, Benezery K, Schiappacasse L, Degardin M, Bondiau PY, Peiffert D, Lefebvre JL, Lacornerie T, Kramar A. Multi institutional phase II study of concomitant stereotactic reirradiation and cetuximab for recurrent head and neck cancer. Radiother Oncol. 2013 Nov;109(2):281-5. doi: 10.1016/j.radonc.2013.08.012. Epub 2013 Nov 18.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. september 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
1. desember 2032
Datoer for studieregistrering
Først innsendt
2. juni 2026
Først innsendt som oppfylte QC-kriteriene
11. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IBA-04-UP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .