Centre Leon Berard
Lyon, France
Not recruitingRadiation skin injury
Study on GR1014 Gel to Prevent Skin Damage from Radiation in Breast Cancer Patients After Lumpectomy
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a skin condition called radiation-induced dermatitis, which can occur in patients receiving radiation therapy for breast cancer. The study is testing a new treatment called GR1014 Cutaneous Gel, which contains an active ingredient known as amifostine thiol. This gel is applied to the skin and is being investigated for its ability to protect the skin from damage caused by radiation therapy. The trial will compare the effects of the GR1014 gel with a placebo gel that looks the same but does not contain the active ingredient.
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of the GR1014 gel in preventing skin damage during radiation therapy for patients who have undergone surgery for localized breast cancer. Participants in the study will be randomly assigned to receive either the GR1014 gel or the placebo gel. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment until the study is completed. This helps ensure that the results are not biased.
Throughout the study, participants will apply the gel to the skin area that will receive radiation treatment. The study will monitor the participants from the start of their radiation therapy until four weeks after the last session. Researchers will assess the condition of the skin and any side effects experienced by the participants. The goal is to determine if the GR1014 gel can effectively prevent or reduce the severity of radiation-induced dermatitis compared to the placebo. Participants will be closely monitored by medical professionals throughout the study to ensure their safety and well-being.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- Provide a dated and signed informed consent form, agreeing to participate in the study.
- Be a female patient who is at least 18 years old. If you can have children, you must use highly effective birth control methods during the study and for 6 months after the last treatment. You also need to have a negative pregnancy test before starting the study treatment.
- Have primary, localized breast cancer that has not spread to other parts of the body. You should have had breast-conserving surgery and need additional radiation therapy. If you had chemotherapy, you must join the study within 4 weeks after the last chemotherapy session. If you did not have chemotherapy, you must join within 8 weeks after surgery. Your hormone receptor status, cancer grade, or HER2 status does not affect your eligibility.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which means you are fully active or have some limitations but can still take care of yourself.
- Be scheduled to receive a specific type of radiation therapy called ultra hypofractionated RT, which involves 26 Gy in 5 sessions on the whole breast.
- Have no signs of skin irritation or dermatitis in the breast area that will receive radiation, as assessed by a specific grading system.
- Be considered by the investigator as able to follow the radiation therapy and study treatment under medical supervision throughout the study.
- Be affiliated with the Social Security System in France.
- Have completed the necessary waiting period after any previous treatments or interventions.
Who cannot join the trial?
3 criteria
- Patients who are not female cannot participate in the study.
- Patients who have a type of skin reaction caused by radiation, known as radiation-induced dermatitis or radiodermatitis, are not eligible.
- Patients who are part of a vulnerable population, which means they might need special protection or care, are not included.
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Verified sites
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Verified Verified Institut Curie - Site Paris
Paris, FranceVerified Institut Gustave Roussy
Villejuif, France
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Investigated drugs
GR1014 is a cutaneous gel being studied for its potential to protect the skin from damage caused by radiation therapy. This gel is applied to the skin and is being tested to see if it can prevent radiodermatitis, which is a common skin condition that occurs as a side effect of radiation treatment in breast cancer patients. The trial aims to determine if this gel is safe and effective for use in patients who have undergone surgery for localized breast cancer and are receiving additional radiation therapy.
What is already known about the treatment
GR1014-CG – This medication is administered as a cutaneous gel and is applied topically to the skin. It is currently being studied in clinical trials as a potential treatment to prevent radiation-induced dermatitis, specifically in patients undergoing radiotherapy for localized breast cancer after lumpectomy. The main therapeutic indication is to act as a radioprotector, reducing skin damage caused by radiation. At the molecular level, it is believed to work by protecting skin cells from the harmful effects of radiation, although the exact mechanism is still under investigation. GR1014-CG is classified pharmacologically as a topical radioprotector.
Investigated diseases
Radiation-induced dermatitis – This condition, also known as radiodermatitis, occurs as a skin reaction to radiation therapy, commonly used in cancer treatment. It typically begins with redness and irritation of the skin in the area exposed to radiation. As the condition progresses, the skin may become dry, itchy, and peel, similar to a sunburn. In more severe cases, the skin can blister, swell, and develop open sores. The severity of radiodermatitis can vary depending on the dose and duration of radiation exposure. It usually develops gradually during the course of treatment and may persist for some time after the therapy has ended.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508728-36-00Protocol codeGRA.05.SPR.0001Estimated enrolment273 patientsSponsorGraegis Pharmaceuticals Limited
sourced from the EU Clinical Trials Register and site verification
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