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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    100
  • sponsor
    Canadian Cancer Trials Group
Updated on 19 April 2021
ct scan
cancer
carcinoma
squamous cell carcinoma
oropharyngeal squamous cell carcinoma

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.

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.

Details
Condition Oropharyngeal Cancer, oropharyngeal carcinoma, carcinoma of oropharynx, cancer, oropharynx
Treatment cisplatin, Radiation
Clinical Study IdentifierNCT03822897
SponsorCanadian Cancer Trials Group
Last Modified on19 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Oropharyngeal Cancer?
Do you have any of these conditions: oropharyngeal carcinoma or Oropharyngeal Cancer or cancer, oropharynx or carcinoma of oropharynx?
Do you have any of these conditions: cancer, oropharynx or oropharyngeal carcinoma or carcinoma of oropharynx or Oropharyngeal Cancer?
Do you have any of these conditions: cancer, oropharynx or Oropharyngeal Cancer or oropharyngeal carcinoma or carcinoma of oropharynx?
Do you have any of these conditions: oropharyngeal carcinoma or carcinoma of oropharynx or cancer, oropharynx or Oropharyngeal Cancer?
Do you have any of these conditions: carcinoma of oropharynx or Oropharyngeal Cancer or oropharyngeal carcinoma or cancer, oropharynx?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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