Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 17, 2020

Primary Completion Date

May 16, 2026

Study Completion Date

May 16, 2027

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
PROCEDURE

Dental avulsion

Before radiotherapy, each subject undergoes a dental evaluation and if it is necessary, dental avulsions if their long-term survival is compromised (see in section 6.1.2) and if they are located in an area at risk to receive more than 40 Gy, so to develop osteoradionecrosis of the jaw. The avulsions should be performed as far as possible from the start of radiotherapy (RT) namely at least 2 weeks before irradiation to allow mucosal healing.

RADIATION

Radiotherapy

"Radiotherapy:~All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT)."

Trial Locations (3)

1000

CHU saint Pierre, Brussels

1070

Hôpital Erasme, Brussels

Institut Jules Bordet, Brussels

Sponsors
All Listed Sponsors
lead

Jules Bordet Institute

OTHER

NCT04452032 - Prospective Pilot Study Evaluating Dental Side Effects of Radiotherapy on Subjects Treated for Head and Neck Cancer | Biotech Hunter | Biotech Hunter