Clincosm LogoSign in Get a demo

EVADER: De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

Sponsor
Canadian Cancer Trials Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03822897
Collaborator
(none)
103
Enrollment
14
Locations
1
Arm
70.3
Anticipated Duration (Months)
7.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Actual Study Start Date :
Feb 20, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Two Treatment Options

Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy

Radiation: 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
Other Names:
  • No available

    • Drug: Cisplatin
    100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
    Other Names:
  • No available

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event-free Survival [5 years]

      Time to first progress event or censoring in year

    Secondary Outcome Measures

    1. Overall Survival [5 years]

      Time to death or censoring in year

    2. Local control [5 years]

      Percentage of patients with local control

    3. Regional Control [5 years]

      Percentage of patients with regional control

    4. Locoregional control [5 years]

      Percentage of patients with local and regional control

    5. Distant Metastasis-Free Survival [5 years]

      Time to distant metastasis or censoring in year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Canadian Cancer Trials Group

    Investigators

    • Study Chair: Scott Bratman, Princess Margaret Cancer Centre, Toronto, ON

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Canadian Cancer Trials Group
    ClinicalTrials.gov Identifier:
    NCT03822897
    Other Study ID Numbers:
    • HN10
    First Posted:
    Jan 30, 2019
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Squamous Cell
    Oropharyngeal Neoplasms
    Squamous Cell Carcinoma of Head and Neck
    Cisplatin

    Study Results

    No Results Posted as of Dec 6, 2021