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NCT Number: NCT03822897

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BCCA - Centre for the North, Prince George, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Cisplatin

Drug

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

Other names: No available

Primary outcomes

  1. Event-free Survival

    Time frame: 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.

Secondary outcomes

  1. Overall Survival

    Time frame: 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. Local-regional Control

    Time frame: 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.

  3. Out-of-field Regional Control

    Time frame: 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.

  4. Distant Metastasis Free Survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Canadian Cancer Trials Group

Network

Registry information

Official study 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

Acronym: EVADER

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Jan 30, 2019
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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