ISRCTN61697120进行中（未招募）2 期
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
Graegis Pharmaceuticals Ltd0 个研究点目标入组 273 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 273
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Dated, signed informed consent obtained from individuals who agree to participate in the study
- •2. Female patients with age =18 years. Those of childbearing potential1 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
- •3. Patients with primary, localised breast cancer without metastases pT1--3, pN0--N1mi, M0, who have undergone breast-conserving surgical excision and require adjuvant RT. If adjuvant chemotherapy is delivered, the patient must be randomised within 4 weeks after the last series of adjuvant chemotherapy. If no adjuvant chemotherapy is delivered, the patient must be randomised within 8 weeks from the last surgery. The patient can be included no matter the status of oestrogen and progesterone receptors, malignancy grade, or HER2 status.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •5. Patients to be treated with ultra hypofractionated RT, 26 Gy in 5 fractions (5.2 Gy) on whole breast (EQD2 > 42.6 Gy for a/ß of 3)
- •6. 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
- •7. 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
- •8. Patients affiliated with the Social Security System (France)
- •9. Patients who have completed the appropriate washout period for any prior interventions or treatments
排除标准
- •1. Pregnant and breastfeeding women
- •2. Patients under any treatment concomitant to RT tested in another clinical study
- •3. Allergies to any of the ingredients in GR1014-CG
- •4. Patients protected by law (legal guardianship or protection)
- •5. Patients unable to adhere to the requirements of the study
- •6. History of thoracic RT
- •7. 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
- •8. 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)
研究者
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