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

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ClinicalTrials.gov Identifier: NCT03822897
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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
Oropharyngeal Cancer Radiation: Radiation Drug: Cisplatin 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : February 20, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
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 Name: No available

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




Primary Outcome Measures :
  1. Event-free Survival [ Time Frame: 5 years ]
    Time to first progress event or censoring in year


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Time to death or censoring in year

  2. Local control [ Time Frame: 5 years ]
    Percentage of patients with local control

  3. Regional Control [ Time Frame: 5 years ]
    Percentage of patients with regional control

  4. Locoregional control [ Time Frame: 5 years ]
    Percentage of patients with local and regional control

  5. Distant Metastasis-Free Survival [ Time Frame: 5 years ]
    Time to distant metastasis or censoring in year



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822897


Contacts
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Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

Locations
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Canada, British Columbia
BCCA - Centre for the North Suspended
Prince George, British Columbia, Canada, V2M 7E9
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Eric Berthelet    604 877-6000      
Canada, Manitoba
CancerCare Manitoba Suspended
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Centre Suspended
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Suspended
Hamilton, Ontario, Canada, L8V 5C2
Kingston Health Sciences Centre Suspended
Kingston, Ontario, Canada, K7L 2V7
Ottawa Hospital Research Institute Suspended
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre Suspended
Toronto, Ontario, Canada, M4N 3M5
University Health Network Suspended
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
The Jewish General Hospital Suspended
Montreal, Quebec, Canada, H3T 1E2
The Research Institute of the McGill University Suspended
Montreal, Quebec, Canada, H4A 3J1
Hotel-Dieu de Quebec Suspended
Quebec City, Quebec, Canada, G1R 2J6
CIUSSS de l'Estrie - Centre hospitalier Suspended
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Allan Blair Cancer Centre Suspended
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Canadian Cancer Trials Group
Investigators
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Study Chair: Scott Bratman Princess Margaret Cancer Centre, Toronto, ON
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03822897    
Other Study ID Numbers: HN10
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents