Description:
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.
Title
- Brief Title: De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
HN10
- NCT ID:
NCT03822897
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | No available | Two Treatment Options |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Two Treatment Options | Other | 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 | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event-free Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Time to first progress event or censoring in year |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Time to death or censoring in year |
Measure: | Local control |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Percentage of patients with local control |
Measure: | Regional Control |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Percentage of patients with regional control |
Measure: | Locoregional control |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Percentage of patients with local and regional control |
Measure: | Distant Metastasis-Free Survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Time to distant metastasis or censoring in year |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Canadian Cancer Trials Group |
Last Updated
May 12, 2021