Recruiting
Phase 2

Radiotherapy vs. Trans-Oral Surgery

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04220749

Conditions

Head and Neck Cancer

Oropharyngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

Trans-Oral Surgery (TOS) + Neck Dissection

Study Details

Brief summary:

The goal of this randomized phase II study is a formal comparison of radiotherapy versus trans-oral surgery as the primary treatment of HPV-negative patients with early-stage oropharyngeal carcinoma.

Conditions

Head and Neck Cancer

Oropharyngeal Squamous Cell Carcinoma

Study ID

NCT04220749

Start date

Jun 25, 2020

Status verified date

Sep, 2020

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Willing to provide informed consent
  • ECOG performance status 0-2
  • Histologically confirmed squamous cell carcinoma
  • HPV-negative tumor, as determined by: negative p16 status, real time PCR or in-situ hybridization. Central confirmation is not required prior to randomization. Equivocal/uncertain HPV status will be allowed on trial.
  • Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)
  • Tumor stage: T1 or T2, with likely negative resection margins at surgery
  • Nodal stage: N0-3. Patients with positive nodal disease and extranodal extension on imaging may be included at the surgeon's discretion, if the nodal disease is deemed resectable by the operating surgeon.
  • Eligible for curative intent treatment, with likely negative resection margins at surgery. For patients where adequate transoral access is in question, they will first undergo an examination under anesthesia prior to randomization to ensure adequate exposure can be obtained.
  • Blood work obtained within 4 weeks prior to randomization, with adequate bone marrow function, hepatic, and renal function, as determined by the investigator.
  • Patient assessed by a radiation oncologist and surgeon and presented at multidisciplinary tumor board prior to randomization. If not feasible, case can be discussed with study Principal Investigator.

Exclusion Criteria:

  • Serious medical comorbidities or other contraindications to radiotherapy, chemotherapy or surgery
  • Prior history of head and neck cancer within 5 years
  • Prior head and neck radiation at any time
  • Metastatic disease
  • Inability to attend full course of radiotherapy or follow-up visits
  • Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer
  • Unable or unwilling to complete QOL questionnaires
  • Pregnant or lactating women

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1, Radiation +/- Chemotherapy

Standard Treatment (Radiation +/- Chemotherapy)

experimental: Arm 2, TOS + Neck Dissection

Trans-oral Surgery (TOS) + Neck Dissection (plus radiation is required)

Interventions

Radiation

Standard of Care: Radiation +/- Chemotherapy

Trans-Oral Surgery (TOS) + Neck Dissection

Trans-Oral Surgery (TOS) + Neck Dissection (plus radiation, if required)

Primary outcome measure

  • Disease-Specific Survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Susan Archer

519-685-8618susan.archer@lhsc.on.ca

Locations

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Danielle MacNeil, MD

519-658-8600Danielle.Macneil@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Sep 4, 2020

Last verified

Sep, 2020

Keywords

  • Radiotherapy
  • Trans-Oral Surgery
  • HPV-Negative
  • Randomized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2020-09-04.