GuARD: GR1014 cutaneous gel Against Radiation Dermatitis
Research type
Research Study
Full title
A randomised, double-blind, vehicle-controlled, multi-centre, parallel-group study to investigate the safety, tolerability, and efficacy of GR1014 cutaneous gel as a topical radioprotector in the prevention of the radiodermatitis occurring with adjuvant radiotherapy for localised breast cancer after lumpectomy
IRAS ID
1009515
Contact name
Patrick RABOISSON
Contact email
Sponsor organisation
Graegis Pharmaceuticals Ldt
ISRCTN Number
ISRCTN61697120
Research summary
This is an interventional, vehicle-controlled, multi-centre, double-blinded, parallel-group trial to assess the ability of GR1014-CG to prevent or reduce radiodermatitis occurring with adjuvant radiotherapy (RT) for localised breast cancer after lumpectomy.
Participants will be randomised in a 1:1:1: ratio into each of the three randomisation arms: vehicle, 4.7% GR1014-CG, and 2.4%
GR1014-CG. A total of 273 participants will be needed for accrual.
Participants will be screened in each centre from the pool of patients with primary, localised breast cancer without metastases pT1--3, pN0-N1mi, M0, who have undergone breastconserving surgical excision and require adjuvant RT (ultra hypofractionated regimen; 26 Gy in 5 fractions over 1 week).
They will be approached for willingness to participate in the study when seen in routine outpatient visits (initial consultation visit of RT).
The study will progress in two steps:
- Safety run-in (in 3 designated investigational centres):~30 participants to allow for ~8-10 evaluable participants per arm, i.e., all 30 participants will have completed the study with 4 weeks follow-up after the last RT treatment. The recruitment will be paused until Data
Safety Monitoring Board (DSMB) decision. Pre-specified early stopping rules will be defined in a DSMB charter to allow for a possible halt of the trial, or one of the active arms if the product or dosage investigated is deemed unsafe.
The PK assessments, serum calcium level measurement and vital signs (heart rate [HR] and blood pressure [BP]) will also be collected in this group of participants.
- After DSMB review and agreement, the recruitment will resume (all investigational centres) until the total of planned study accrual is reached.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0121
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Favourable Opinion