Perioperative treatment with Tranexamic Acid (TXA) in melanoma; prognostic and treatment related impact of the plasminogen-plasmin pathway
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,204
- 试验地点
- 7
- 主要终点
- Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome.
研究概览
简要总结
To test if perioperative treatment with TXA is superior to placebo and reduces the early relapse rates by >10%, for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients: Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade higher than T2b), defined as either: Breslow thickness >1.0-2.0 mm with presence of ulceration or Breslow thickness >2.0 mm regardless of ulceration status Eligible for surgery (wide local excision and sentinel lymph node biopsy). >/=18 years of age and </=80 years of age Signed Informed Consent Form
排除标准
- •Patients: With prior history of invasive melanoma Thromboembolic events within the last 3 months Pregnancy * Active breast feeding Known allergy or hypersensitivity to TXA Known and treated epilepsia or previous seizures eGFR 0-50
结局指标
主要结局
Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome.
Histopathological confirmed relapse, defined as either local, regional (in transit or lymph node) or systemic relapses. Systemic metastases suspected on PET / CT/ MR will be used if a biopsy is not possible. We will calculate relapse risk proportions for each treatment arm as a binary outcome.
次要结局
- Adverse events, summarised according to grade: Mild: defined as the patient’s report of abdominal pain, diarrhoea or nausea. Severe: thromboembolic events, verified radiologically.
- Postoperative complications, summarised according to the type and postoperative timepoint, is defined as binary outcomes as bleeding, seroma or infection
- Melanoma specific survival: defined as the period from the date of surgery (wide local excision and sentinel lymph node biopsy) to the date of death from suspected systemic melanoma (histopathological confirmed relapse or systemic metastases suspected on PET / CT / MR) or the date of completed 5 years follow-up.
- Overall survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of death from all causes or the date of finalised 5 years follow-up.
- Relapse free survival: defined as the period from the date of surgery (re-excision and sentinel node) to the date of histopathological confirmed relapse (local, regional or systemic), death from all causes or the data or completed 2 years follow-up.
研究者
Marie Louise Bønnelykke-Behrndtz
Scientific
Aarhus University Hospital