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GuARD: GR1014 cutaneous gel Against Radiation Dermatitis
EU CTIS ID: 2023-508728-36-00
What this study is testing
To investigate the safety, tolerability, and efficacy of GR1014-CG (4.7%; 2.4%) as a treatment to prevent radiodermatitis occurring with adjuvant ultra hypofractionated RT for localised, non-metastatic breast cancer after lumpectomy, versus vehicle gel.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Dated, signed informed consent obtained from individuals who agree to participate in the study.
- Female patients with age ≥18 years. Those of childbearing potential must be using highly effective contraception methods during the study and for 6 months after the last administration of the study treatment and have a negative pregnancy test at screening and no more than 10 days prior to the administration of the first dose of study treatment.
- 3.a. Patients with primary, localised breast cancer without metastases pTis, T1-3, pN0-N1mi, M0, who have undergone breast-conserving surgical excision and require adjuvant RT. The patients should be randomised after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of oestrogen and progesterone receptors, malignancy grade, or HER2 status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients to be treated with ultra hypofractionated RT, 26 Gy in 5 fractions (5.2 Gy) on whole breast (EQD2 > 42.6 Gy for α/β of 3).
- Patients with no signs of dermatitis in the breast area to be irradiated, i.e., assessed Grade 0 as per CTCAE LV radiation dermatitis grading.
You likely can't join if
- Pregnant and breastfeeding women.
- Patients under any treatment concomitant to RT tested in another clinical study.
- Allergies to any of the ingredients in GR1014-CG
- Patients protected by law (legal guardianship or protection).
- Patients unable to adhere to the requirements of the study.
- History of thoracic RT.
See the full eligibility criteria
- Dated, signed informed consent obtained from individuals who agree to participate in the study.
- Female patients with age ≥18 years. Those of childbearing potential must be using highly effective contraception methods during the study and for 6 months after the last administration of the study treatment and have a negative pregnancy test at screening and no more than 10 days prior to the administration of the first dose of study treatment.
- 3.a. Patients with primary, localised breast cancer without metastases pTis, T1-3, pN0-N1mi, M0, who have undergone breast-conserving surgical excision and require adjuvant RT. The patients should be randomised after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of oestrogen and progesterone receptors, malignancy grade, or HER2 status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients to be treated with ultra hypofractionated RT, 26 Gy in 5 fractions (5.2 Gy) on whole breast (EQD2 > 42.6 Gy for α/β of 3).
- Patients with no signs of dermatitis in the breast area to be irradiated, i.e., assessed Grade 0 as per CTCAE LV radiation dermatitis grading.
- Patients whom the investigator has deemed able to comply with the RT and investigational treatment done under the supervision of the medical personnel throughout the study period.
- Patients affiliated with the Social Security System (France).
- Patients who have completed the appropriate washout period for any prior interventions or treatments.
- Pregnant and breastfeeding women.
- Patients under any treatment concomitant to RT tested in another clinical study.
- Allergies to any of the ingredients in GR1014-CG
- Patients protected by law (legal guardianship or protection).
- Patients unable to adhere to the requirements of the study.
- History of thoracic RT.
- Participants with the presence of skin rash, ulceration, unhealed surgical wounds, biopsy sites, or open wound in the breast or chest area at visit 2.
- Patients suffering from scleroderma, auto-immune disease, micro-vascular diseases, collagen tissue diseases, lupus, pre-existing loss of skin integrity, active eczema in the region to be treated or with a history of any of the following: drug-induced severe cutaneous adverse reaction (SCAR; including, but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis [SJS/TEN], or drug reaction with eosinophilia and systemic symptoms).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.