| Title |
Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial |
| Protocole ID |
PRESERVE |
| ClinicalTrials.gov ID |
NCT03997643 |
| Cancer Type(s) |
Head and Neck |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
|
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
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| Principal Investigator |
Dr. Houda Bahig
|
| Coordinator |
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility 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
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Groupe d'étude en oncologie du Québec