Head and Neck Cancer
Conditions
Keywords
Radiation Therapy, Oral Cavity Squamous Cell Carcinoma, Randomized Trial
Brief summary
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options.
Detailed description
The goal of this randomized treatment study is to formally compare quality of life in patients with at least one pN0 hemi-neck after resection of a squamous cell carcinoma of the oral cavity treated with a primary radiation therapy versus a secondary targeted radiation therapy approach, to provide a high level of evidence to guide the selection of treatment options. The study will require a sample size of 90 patients randomized in a 2:3 between the two arms. Arm 1 (standard radiation therapy to tumor location and surrounding area) and Arm 2 (targeted radiation therapy to tumor location). Patients will be followed for a total of 5 years.
Interventions
RADIATIONRadiotherapy to all dissected areas
Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
RADIATIONOmit radiation to pN0 neck
post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing to provide informed consent * ECOG performance status 0-2 * Histologically confirmed, resected oral cavity squamous cell carcinoma with at least ipsilateral selective neck disection * Patient has pathological features that are indications for PORT: positive or close (≤ 3 mm) margin, presence of LVI or PNU, pT3 or pT4 disease, positive lymph nodes, and PORT is recommended by treating physician * Pathologically lympth node negative in at least one dissected hemi-neck with at least 10 nodes recovered in each pN0 hemi-neck
Exclusion criteria
* Serious medical comorbidities or other contraindications to radiotherapy * Prior history of head and neck cancer within 5 years * Any other active invasive malignancy, except non-melanotic skin cancers * Prior head and neck radiation at any time * Prior oncologic head and neck surgery in the oral cavity or neck * Metastatic disease * Locoregional disease recurrence identified following surgical resection but prior to the start of radiotherapy * Inability to attend full course of radio therapy or follow-up visits * Unable or unwilling to complete QoL questionnaires * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional failure in the pN0 hemi-neck (s) | Baseline to 5 years | Rate of relapse in the pN0 neck in Arm 2 compared to historical controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Status Quality of life | Baseline up to 12 months | Assessed with the EORTC EQ-5D-5L scale |
| Overall survival | Baseline to 5 years | Defined as time from randomization to death from any cause |
| Disease free survival | Baseline to 5 years | Defined as the measure of time after treatment during which no sign of cancer is found |
| Local recurrence | Baseline to 5 years | Defined as Cancer that has recurred at or near the same place as the primary tumor, usually after a period of time during which the cancer could not be detected. |
| Regional recurrence | Baseline to 5 years | Defined as recurrence that occurs in the lymph nodes and tissue located in the vicinity of your original cancer |
| Swallowing Quality of life | Baseline up to 12 months | Assessed with the MD Anderson Dysphagia Inventory (MDADI) scale |
| Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from unsalvageable neck recurrence | Baseline 5 years | Rate of salvage treatment (surgery +/- radiotherapy) in the pN0 neck and freedom from |
| Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization | Randomization to 1 year post randomization | Rate of feeding tub insertion and rate of feeding tube use at 1-year post randomization |
| Swallowing function | Baseline to 1 year | Measured by the Modified Barium Swallow Impairment (MBsimp) score |
| Rate of toxicity | Baseline to 5 years | Assessed using the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4 |
| Rate of failure in the clinically node negative neck | Baseline to 5 years | defined as time from randomization to failure in the cN0 neck |
| Locoregional recurrence | Baseline to 5 years | Defined as the recurrence of cancer cells at the same site as the original tumor and/or the regional lymph nodes after a disease free period. |
Countries
Canada, Ireland, United Kingdom, United States
Outcome results
None listed