De-escalatie radiotherapie bij patiënten met een laag risico HPV-gerelateerd orofaryngeaal plaveiselcelcarcinoom (EVADER)
Een fase II-onderzoek met één arm naar electieve volume-aangepaste de-escalatieradiotherapie (EVADER) bij patiënten met HPV-gerelateerd orofaryngeaal plaveiselcelcarcinoom met een laag risico
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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British Columbia
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Prince George, British Columbia, Canada, V2M 7E9
- BCCA - Centre for the North
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- The Research Institute of the McGill University
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Montreal, Quebec, Canada, H3T 1E2
- The Jewish General Hospital
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Québec, Quebec, Canada, G1R 2J6
- Hotel-Dieu de Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- CIUSSS de l'Estrie - Centre hospitalier
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
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
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) |
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
Andere namen:
100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Event-free Survival
Tijdsspanne: 2 years
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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:
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2 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Survival
Tijdsspanne: 2 years
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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
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Local-regional Control
Tijdsspanne: 2 years
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Local-regional control is defined as the time from the date of registration to the date of any of the following, whichever comes first:
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2 years
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Out-of-field Regional Control
Tijdsspanne: 2 years
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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
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Distant Metastasis Free Survival
Tijdsspanne: 2 years
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Scott Bratman, Princess Margaret Cancer Centre, Toronto, ON
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Stomatognatische ziekten
- Neoplasmata per site
- Neoplasmata
- Hoofd- en nekneoplasmata
- KNO-ziekten
- Faryngeale neoplasmata
- Otorinolaryngologische neoplasmata
- Faryngeale ziekten
- Orofaryngeale neoplasmata
- Fysieke fenomeen
- Anorganische chemicaliën
- Chloorverbindingen
- Stikstofverbindingen
- Platinumverbindingen
- Cisplatine
- Bestraling
Andere studie-ID-nummers
- HN10
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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