Radiotherapy vs. Trans-Oral Surgery for HPV-Negative Oropharyngeal Squamous Cell Carcinoma

NCT ID: NCT04220749

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2028-02-29

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.

Detailed Description

This study is designed as a randomized phase II study. Patients will be randomized between current standard of care treatment (Arm 1) vs. TOS (Arm 2) in a 1:1 ratio. Additionally, patients will be stratified according to T stage (T1 vs. T2); N stage (N0/1 vs. N2/3)

The randomized phase II design is required for three reasons:

1. The randomization will provide an appropriate control group to serve as a comparator for the experimental arm. Historical or contemporaneous non-randomized controls would not be appropriate due to the multitude of biases that could be introduced by patient selection and other confounders.

2. A small sample size will allow for adequate power to assess for progression-free survival, and also an assessment of quality of life, overall survival and toxicity.

3. The results will allow for a decision as to whether a multi-institutional phase III trial is warranted, and inform the design of such a trial.

Conditions

Head and Neck Cancer; Oropharyngeal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1, Radiation +/- Chemotherapy

Standard Treatment (Radiation +/- Chemotherapy)

Group Type: ACTIVE_COMPARATOR

Radiation

Intervention Type: RADIATION

Standard of Care: Radiation +/- Chemotherapy

Arm 2, TOS + Neck Dissection

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

Group Type: EXPERIMENTAL

Trans-Oral Surgery (TOS) + Neck Dissection

Intervention Type: PROCEDURE

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

Interventions

Radiation

Standard of Care: Radiation +/- Chemotherapy

Intervention Type: RADIATION

Trans-Oral Surgery (TOS) + Neck Dissection

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

Intervention Type: PROCEDURE

Other Intervention Names

Chemotherapy, if required; Radiation, if required

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle MacNeil, M.D.

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Program, London Health Sciences Centre

Locations

London Regional Cancer Program

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Susan Archer

Role: CONTACT

susan.archer@lhsc.on.ca

519-685-8618

Facility Contacts

Danielle MacNeil, MD

Role: primary

Danielle.Macneil@lhsc.on.ca

519-658-8600

Other Identifiers

ORATOR 3

Identifier Type: -

Identifier Source: org_study_id