Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial

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.

Eligibility

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

Conditions2

Locations1 site

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