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

NCT04220749 | Recruiting Phase 2 DMC

• 1 other identifier: ORATOR 3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Disease-Specific Survival

  Time from randomization to death from cancer

  5 years

Secondary Outcomes (14)

• Overall Survival

  5 years

• Progression-Free Survival

  5 years

• Local-Regional Failure

  5 years

• Distant Failure

  5 years

• Any Failure

  5 years

Study Arms (2)

Arm 1, Radiation +/- Chemotherapy

ACTIVE COMPARATOR

Standard Treatment (Radiation +/- Chemotherapy)

Radiation: Radiation

Arm 2, TOS + Neck Dissection

EXPERIMENTAL

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

Procedure: Trans-Oral Surgery (TOS) + Neck Dissection

Interventions

Radiation RADIATION

Standard of Care: Radiation +/- Chemotherapy

Also known as: Chemotherapy, if required

Arm 1, Radiation +/- Chemotherapy

Trans-Oral Surgery (TOS) + Neck Dissection PROCEDURE

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

Also known as: Radiation, if required

Arm 2, TOS + Neck Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Radiation; Drug Therapy; Neck Dissection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Physical Phenomena; Therapeutics; Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• Danielle MacNeil, M.D.

  London Regional Cancer Program, London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Archer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 Arm study randomized in a 1:1 ratio

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: June 25, 2020
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

CA (1)