| Titre |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled,
Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated with Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer. |
| Protocole ID |
GTI-4419-301 |
| ClinicalTrials.gov ID |
NCT03689712 |
| Type(s) de cancer |
ORL |
| Phase |
Phase III |
| Stade |
Localement avancé |
| Type étude |
Support |
| Médicament |
Superoxide Dismutase Mimetic GC4419 |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Phuc-Félix Nguyen Tân
|
| Coordonnateur(trice) |
Mom Phat
514-890-8000 poste 11171
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- squamous cell carcinoma of the head and neck
- treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
- Treatment plan to receive standard cisplatin monotherapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Adequate hematologic, renal and liver function
- Negative serum pregnancy test
- Use of effective contraception
|
| Critètes d'exclusion |
- Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
- Metastatic disease
- Prior radiotherapy to the region of the study cancer or adjacent anatomical
- Prior induction chemotherapy
- Receiving any approved or investigational anti-cancer agent other than those provided for in this study
- Concurrent participation in another interventional clinical study
- Inability to eat soft solid food at baseline
- Malignant tumors other than HNC within the last 5 years
- Active infectious disease excluding oral candidiasis
- Presence of oral mucositis at baseline
- Known history of HIV or active hepatitis B/C
- Female patients who are pregnant or breastfeeding
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure
|
Groupe d'étude en oncologie du Québec