Radiodermatitis; AcutePhase 2GuARDNCT07192588
A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer
A Phase 2 study testing GR1014-CG 2.4%, Radiation Therapy and GR1014-CG 4.7% in people with Radiodermatitis; Acute, run by Graegis Pharmaceuticals Ltd at 4 sites in 2 countries.
Trial summary
This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after breast-conserving surgery for early-stage breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiodermatitis; Acute
- What is being tested?
- GR1014-CG 2.4%, Radiation Therapy and GR1014-CG 4.7%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Jul 2024to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with age ≥18 years. Those of childbearing potential must be using highly effective contraception methods during the study and for 30 days 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
- Patients with primary, localized 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 randomized after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of estrogen and progesterone receptors, malignancy grade, or HER2 status.
- 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 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 who have completed the appropriate washout period for any prior interventions or treatments
Who cannot join
- Pregnant and breastfeeding women
- Patients under any treatment concomitant to radiotherapy 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Institut Bergonié
Bordeaux, 33076
Centre Léon Bérard
Lyon, 69373
Institut Gustave Roussy
Villejuif, 94805
United Kingdom1 site
The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
Sutton, SM2 5PT
About this study
Official 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
This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after breast-conserving surgery for early-stage breast cancer. The study is for women aged 18 and older who have had surgery to remove a breast tumor and need radiation therapy.
The main goals of the study are to find out:
Read more
- If GR1014-CG is safe to use
- If the gel can prevent or lower the severity of skin irritation caused by RT.
During the study participants will,
- Be randomly assigned to use one of two strengths of GR1014-CG (4.7% or 2.4%) or a placebo gel (a gel with no active drug).
- Apply the gel to the breast before each radiation session for 5 days.
- Visit the clinic once a week for 4 weeks to check their skin and overall health. At the end of the 4th week, if there are still signs of irritation participants will come to the clinic for a checkup 2 weeks after, and then again 2 weeks after if the irritation is still observed.
- Keep a diary to record any pain or itching they may feel.
Read the detailed description
Adjuvant radiation therapy (RT) decreases the chances of local cancer reappearance and improves survival rates. However, radiotherapy is often associated with side effects, including radiation-induced dermatitis (radiodermatitis). Symptoms of radiation-induced dermatitis include skin redness (erythema), swelling (oedema), dry or moist peeling of the skin (desquamation), and varying degrees of pain. GR1014 cutaneous gel (GR1014-CG) contains amifostine thiol (GR1014), an active substance with well-established radioprotective effects. The protective properties of GR1014-CG are potentially beneficial in preventing radiodermatitis, particularly in patients with breast cancer treated with adjuvant RT. GR1014 CG is designed to be topically applied to the skin before each RT session without any modifications to the planned course of RT.
This is a dose-finding, phase-2 trial to investigate the safety, tolerability, and efficacy of GR1014-CG as a topical radioprotector in the reduction of radiodermatitis occurring in patients treated with adjuvant ultra-hypofractionated RT (26 Gy in 5 fractions over 1 week) for localized, non-metastatic breast cancer after tumor removal (lumpectomy) versus vehicle gel.
- Conditions
- Radiodermatitis; Acute
- Being tested
- GR1014-CG 2.4%, Vehicle Gel, Radiation Therapy, GR1014-CG 4.7%
- Keywords
- Radiotherapy, Amifostine thiol, Radiodermatitis, Prevention, Cutaneous, Breast Cancer, Topical
- Medical subject headings
- Radiodermatitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR1014-CG 2.4%Drug
Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL
Vehicle GelDrug
The same topical formulation as GR1014-CG without the active ingredient amifostine thiol
Radiation TherapyRadiation
Ultra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast
GR1014-CG 4.7%Drug
Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| GR1014-CG 4.7% | Experimental | GR1014-CG 4.7% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation Receives: Radiation: Radiation Therapy; Drug: GR1014-CG 4.7% |
| GR1014-CG 2.4% | Experimental | GR1014-CG 2.4% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation Receives: Drug: GR1014-CG 2.4%; Radiation: Radiation Therapy |
| Vehicle Gel | Placebo comparator | Vehicle Gel will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation Receives: Drug: Vehicle Gel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0)
As per CTCAE - Radiation Dermatitis: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation.
Grade 1: Faint erythema or dry desquamation; Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema; Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated; Grade 5: Death
Measured: At any time between the first radiotherapy session and 4 weeks after the last one
Secondary outcomes (11)
Percentage of Participants with a Radiodermatitis grade ≥2 (CTCAE LV)
Measured: At any time between the first radiotherapy session and 4 weeks after the last one
Percentage of Participants with No Radiation Dermatitis (CTCAE LV)
Measured: 4 weeks after the last radiotherapy session (at Visit 10)
Maximum Grade of Radiodermatitis (CTCAE LV) Reached in each Participant
Measured: Between the first radiotherapy session and 4 weeks after the last one
Assessments of Radiodermatitis Grade (CTCAE LV)
Measured: Between the first radiotherapy session and up to 8 weeks after the last one
Time to Onset of Radiodermatitis Grade ≥2 (CTCAE LV).
Measured: From the first radiotherapy session and up to 8 weeks after the last one
Duration of Radiodermatitis Grade ≥2 (CTCAE LV)
Measured: From the first session of radiotherapy and up to 8 weeks after the last one
Percentage of participants with severe radiodermatitis (grade ≥3; CTCAE LV)
Measured: At any time between the first radiotherapy session and 4 weeks after the last one
Number of cases of side effects of radiotherapy other than radiodermatitis
Oedema; hyperpigmentation; skin infection; need for topical and systemic antibiotics; need for topical steroids; need for analgesics; need for silicone-based dressings
Measured: At any time between the first radiotherapy session and up to 8 weeks after the last one
Absolute change from baseline in weekly averaged worst skin pain score in the irradiated area
Worst pain intensity (during the last 24 hours) will be scored daily on a 0-10 Numeric Rating Scale. Zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: From date of screening visit and up to 8 weeks after the last radiotherapy session
Absolute change from baseline in weekly averaged peak pruritus score in the irradiated area.
Peak pruritus intensity (during the last 24 hours) scored daily on a 0-10 NRS. Zero is equivalent to no pruritus (itching) and 10 indicates the worst possible pruritus.
Measured: From date of screening visit and up to 8 weeks after the last radiotherapy session
Total score and sub-scores of Dermatology Life Quality Index (DLQI)
DLQI is a ten-item questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: From the first radiotherapy session and up to 8 weeks after the last one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start26 Jul 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiodermatitis; AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Graegis Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Excelya
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192588
- Sponsor's protocol ID
- GRA.05.SPR.0001
- Other IDs
- 2023-508728-36-00, 1009515, 2023
- Acronym
- GuARD
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07192588
- Acronym / sponsor ID
- GuARD / GRA.05.SPR.0001
- Conditions
- Radiodermatitis; Acute
- Keywords
- Radiotherapy, Amifostine thiol, Radiodermatitis, Prevention, Cutaneous, Breast Cancer, Topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Graegis Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Excelya
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after breast-conserving surgery for early-stage breast cancer. The study is for women aged 18 and older who have had surgery to remove a breast tumor and need radiation therapy.
The main goals of the study are to find out:
- If GR1014-CG is safe to use
- If the gel can prevent or lower the severity of skin irritation caused by RT.
During the study participants will,
- Be randomly assigned to use one of two strengths of GR1014-CG (4.7% or 2.4%) or a placebo gel (a gel with no active drug).
- Apply the gel to the breast before each radiation session for 5 days.
- Visit the clinic once a week for 4 weeks to check their skin and overall health. At the end of the 4th week, if there are still signs of irritation participants will come to the clinic for a checkup 2 weeks after, and then again 2 weeks after if the irritation is still observed.
- Keep a diary to record any pain or itching they may feel.
Detailed description
Adjuvant radiation therapy (RT) decreases the chances of local cancer reappearance and improves survival rates. However, radiotherapy is often associated with side effects, including radiation-induced dermatitis (radiodermatitis). Symptoms of radiation-induced dermatitis include skin redness (erythema), swelling (oedema), dry or moist peeling of the skin (desquamation), and varying degrees of pain. GR1014 cutaneous gel (GR1014-CG) contains amifostine thiol (GR1014), an active substance with well-established radioprotective effects. The protective properties of GR1014-CG are potentially beneficial in preventing radiodermatitis, particularly in patients with breast cancer treated with adjuvant RT. GR1014 CG is designed to be topically applied to the skin before each RT session without any modifications to the planned course of RT.
This is a dose-finding, phase-2 trial to investigate the safety, tolerability, and efficacy of GR1014-CG as a topical radioprotector in the reduction of radiodermatitis occurring in patients treated with adjuvant ultra-hypofractionated RT (26 Gy in 5 fractions over 1 week) for localized, non-metastatic breast cancer after tumor removal (lumpectomy) versus vehicle gel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GR1014-CG 4.7% | Experimental | Radiation: Radiation Therapy, Drug: GR1014-CG 4.7%GR1014-CG 4.7% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation |
| GR1014-CG 2.4% | Experimental | Drug: GR1014-CG 2.4%, Radiation: Radiation TherapyGR1014-CG 2.4% will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation |
| Vehicle Gel | Placebo comparator | Drug: Vehicle Gel, Radiation: Radiation TherapyVehicle Gel will be applied topically on the breast skin surface to be irradiated 15-30 min each day of the radiotherapy, 15-30 min before irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients with age ≥18 years. Those of childbearing potential must be using highly effective contraception methods during the study and for 30 days 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
- Patients with primary, localized 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 randomized after having recovered from the last surgery and, if delivered, the adjuvant chemotherapy. The patients can be included no matter the status of estrogen and progesterone receptors, malignancy grade, or HER2 status.
- 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 radiation dermatitis grading
Key exclusion criteria (8 listed)
- Pregnant and breastfeeding women
- Patients under any treatment concomitant to radiotherapy 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR1014-CG 2.4%Topical gel formulation of amifostine thiol (GR1014) at 25 mg/mL | Drug | GR1014-CG 2.4% |
| Vehicle GelThe same topical formulation as GR1014-CG without the active ingredient amifostine thiol | Drug | Vehicle Gel |
| Radiation TherapyUltra hypofractionated RT, 26 Gy in 5 daily fractions (5.2 Gy) given over 1 week on the whole breast | Radiation | GR1014-CG 2.4%, GR1014-CG 4.7%, Vehicle Gel |
| GR1014-CG 4.7%Topical gel formulation of amifostine thiol (GR1014) at 50 mg/mL | Drug | GR1014-CG 4.7% |
Primary outcome
Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0)
Time frame: At any time between the first radiotherapy session and 4 weeks after the last one
As per CTCAE - Radiation Dermatitis: A finding of cutaneous inflammatory reaction occurring as a result of exposure to biologically effective levels of ionizing radiation. Grade 1: Faint erythema or dry desquamation; Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema; Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion; Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated; Grade 5: Death
11 secondary outcomes
Percentage of Participants with a Radiodermatitis grade ≥2 (CTCAE LV)
Time frame: At any time between the first radiotherapy session and 4 weeks after the last one
Percentage of Participants with No Radiation Dermatitis (CTCAE LV)
Time frame: 4 weeks after the last radiotherapy session (at Visit 10)
Maximum Grade of Radiodermatitis (CTCAE LV) Reached in each Participant
Time frame: Between the first radiotherapy session and 4 weeks after the last one
Assessments of Radiodermatitis Grade (CTCAE LV)
Time frame: Between the first radiotherapy session and up to 8 weeks after the last one
Time to Onset of Radiodermatitis Grade ≥2 (CTCAE LV).
Time frame: From the first radiotherapy session and up to 8 weeks after the last one
Duration of Radiodermatitis Grade ≥2 (CTCAE LV)
Time frame: From the first session of radiotherapy and up to 8 weeks after the last one
Percentage of participants with severe radiodermatitis (grade ≥3; CTCAE LV)
Time frame: At any time between the first radiotherapy session and 4 weeks after the last one
Number of cases of side effects of radiotherapy other than radiodermatitis
Time frame: At any time between the first radiotherapy session and up to 8 weeks after the last one
Absolute change from baseline in weekly averaged worst skin pain score in the irradiated area
Time frame: From date of screening visit and up to 8 weeks after the last radiotherapy session
Absolute change from baseline in weekly averaged peak pruritus score in the irradiated area.
Time frame: From date of screening visit and up to 8 weeks after the last radiotherapy session
Total score and sub-scores of Dermatology Life Quality Index (DLQI)
Time frame: From the first radiotherapy session and up to 8 weeks after the last one
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GR1014-CG 2.4%, Radiation Therapy and GR1014-CG 4.7% in people with Radiodermatitis; Acute, run by Graegis Pharmaceuticals Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with No Radiation Dermatitis as Assessed by CTCAE Latest Version (LV) (Grade of 0) (time frame: At any time between the first radiotherapy session and 4 weeks after the last one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.