Clinical Trial Finder

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

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.

Arms

Active Comparator: Standard Radiotherapy

Radiotherapy to all dissected areas

Experimental: Radiotherapy to smaller treatment area

Omit radiation to pN0 neck

Interventions

Radiation: - Radiotherapy to all dissected areas

Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas

Radiation: - Omit radiation to pN0 neck

post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck