| TITRE |
(EN) Preservation of Swallowing in Resected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects: A Randomized Trial |
| PROTOCOLE ID |
PRESERVE |
| CLINICAL TRIAL.gov ID |
NCT03997643 |
| TYPE(S) DE CANCER |
ORL |
| PHASE |
Phase II |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Houda Bahig
|
| COORDONATEUR(RICE) |
Mom Phat
mom.phat.chum@ssss.gouv.qc.ca
514-890-8000 poste 11171
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
