Early-Stage Squamous Cell Carcinoma of the Oropharynx Clinical Trial
— ORATOROfficial title:
A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)
| Verified date | March 2023 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation. This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.
| Status | Active, not recruiting |
| Enrollment | 68 |
| Est. completion date | September 2023 |
| Est. primary completion date | September 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - age 18 or older - willing to provide informed consent - ECOG performance status 0-2 - Histologically confirmed squamous cell carcinoma primary rumour site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx) - Tumour stage:T1 or T2, with likely negative resections at surgery - Nodal stage: N0, N1, or N2 (less than or equal to 4 cm in maximum dimension in any plane, on either side of the neck), without extranodal extension on pre-randomization imaging. - Patient assessed at head and neck multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumour board prior to randomization. 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 - Neck disease with unknown primary site - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | |
| Canada | London Regional Cancer Program of the Lawson Health Research Institute | London | Ontario |
| Canada | Jewish General Hospital | Montréal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | University Health Network | Toronto | Ontario |
| Canada | British Columbia Cancer Agency | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute |
Australia, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Quality of Life | 1-year post treatment | ||
| Secondary | Overall Survival | At the end of 3 years and at the end of 5 years | ||
| Secondary | Progression-free survival | At the end of 3 years and at the end of 5 years | ||
| Secondary | Quality of life at other time points | Every 6 months for 5 years from 1st date of treament | ||
| Secondary | Toxicity | 5 years from date of first treatment | ||
| Secondary | Swallowing Function | 5 years from date of first treatment |