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De-eskalerende strålebehandling hos patienter med lavrisiko HPV-relateret orofarynx pladecellekarcinom (EVADER)

2. november 2026 opdateret af: Canadian Cancer Trials Group

Et fase II enkeltarmsforsøg med elektiv volumenjusteret de-eskaleringsstrålebehandling (EVADER) hos patienter med lavrisiko HPV-relateret orofarynx pladecellekarcinom

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.

These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

103

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Prince George, British Columbia, Canada, V2M 7E9
        • BCCA - Centre for the North
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Dr. H. Bliss Murphy Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • The Research Institute of the McGill University
      • Montreal, Quebec, Canada, H3T 1E2
        • The Jewish General Hospital
      • Québec, Quebec, Canada, G1R 2J6
        • Hotel-Dieu de Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CIUSSS de l'Estrie - Centre hospitalier
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with pathologically proven diagnosis of HPV-related OPSCC
  • Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)
  • Patients must be eligible for definitive RT or CRT
  • Must be ≥ 18 years of age
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in either English or French
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient registration
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
  • The following radiological investigations must be done within 8 weeks of randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue primary tumors); PET-CT scan.
  • Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin-fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays described in Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual for details
  • Patient must consent to provision of samples of blood and plasma (for circulating cell free DNA) in order that the specific correlative marker assays described may be conducted.
  • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria:

  • Previous chemotherapy or radiotherapy treatment for head and neck cancer
  • Patients with an unknown primary.

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
Andet: Experimental arm

This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.

  • Option 1 (Chemoradiotherapy):

Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks

  • Option 2 (Radiotherapy Alone):

Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week)
Stråling: Radiation

35 fractions, 5/wk, 7 wks 70Gy/56Gy, or

35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or

35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy

Andre navne:
  • Ingen tilgængelig
Medicin: Cisplatin

100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks

Andre navne:
  • Ingen tilgængelig

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event-free Survival
Tidsramme: 2 years

Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events:

  • Progression.
  • Surgery.
  • Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure.
  • Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 2 years

For patients who have died, overall survival is calculated in months from the day of registration to date of death. Otherwise, overall survival is censored at the last day the patient is known alive (LKA). The outcome is reported as the proportion of patients who remain alive at 2 years.
2 years
Local-regional Control
Tidsramme: 2 years

Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:

  • Surgery of primary tumour at any time performed for clinical or radiological disease persistence/progression/recurrence with tumour present/unknown on final pathology.
  • Neck dissection > 20 weeks from the end of radiation therapy performed for clinical or radiological (RECIST 1.1) disease persistence/progression/recurrence within target volumes with tumour present/unknown on final pathology.
  • Neck dissection at any time after registration performed for clinical or radiological disease recurrence/progression outside the target volumes or without documentation of the site of failure with tumour present/unknown on final pathology.
  • the first record of appearance (radiological or clinical) of local or regional disease progression. The outcome is reported as the proportion of patients who remain local-regional control free at 2 years.
2 years
Out-of-field Regional Control
Tidsramme: 2 years

Time to out-of-field regional failure is defined as the time from the date of registration to the date of the first record of appearance of regional progression/recurrence outside the treatment field , or to the date of neck dissection at any time after registration with tumour present/unknown performed for clinical or radiological disease progression outside the target volumes whichever comes first. The outcome is reported as the proportion of patients who remain out-of-field regional control free at 2 years.
2 years
Distant Metastasis Free Survival
Tidsramme: 2 years

Distant metastasis free survival is defined as the time from the date of registration to the date of first record of appearance of distant metastasis or death for any cause. Local-regional failure or second cancers diagnosed before the distant metastases are not considered events of interest for this endpoint. Subjects alive and free of distant metastasis are censored at the date of the most recent follow-up examination. The outcome is reported as the proportion of patients who remain distant metastasis event-free at 2 years.
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Canadian Cancer Trials Group

Efterforskere

  • Studiestol: Scott Bratman, Princess Margaret Cancer Centre, Toronto, ON

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)

28. juni 2019

Primær færdiggørelse (Faktiske)

25. juni 2024

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

18. januar 2019

Først indsendt, der opfyldte QC-kriterier

29. januar 2019

Først opslået (Faktiske)

30. januar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HN10

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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