2024-516271-32-00招募中3 期
RACE-trial: Neoadjuvant Radiochemotherapy versus Chemotherapy for Patients with Locally Advanced, Potentially Resectable Adenocarcinoma of the Gastroesophageal Junction (GEJ) A randomized phase III joint study of the AIO, ARO and DGAV
Universitat Heidelberg30 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2024年11月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 30
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The primary endpoint of the study is to investigate whether the addition of preoperative radiochemotherapy is superior to perioperative chemotherapy alone in the treatment of resectable GEJ adenocarcinoma by improving progression-free survival in patients undergoing oncologically adequate surgery (D2 resection and appropriate mediastinal lymphadenectomy).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically proven, locally advanced and potentially resectable adenocarcinoma of the gastroesophageal junction (GEJ) (Siewert I- III) that is: cT3-4, any N, or cT2 N+ M0 according to AJCC 8th edition
- •Written informed consent obtained before randomization
- •Negative pregnancy test for women of childbearing potential within 7 days of commencing study treatment. Males and females of reproductive potential must agree to practice highly effective contraceptive measures*** during the study and for 6 months after the end of study treatment. Male patients must also agree to refrain from father a child during treatment and up to 6 months afterwards and additionally to use a condom during treatment period. Their female partner of childbearing potential must also agree to use an adequate contraceptive measure.
- •Patients* must be candidates for potential curative resection as determined by the treating surgeon.
- •ECOG performance status 0-1
- •Age 18 years or above
- •Adequate hematologic function with absolute neutrophil count (ANC) ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l and hemoglobin ≥ 9.0 mg/dl
- •INR <1.5 and aPTT<1.5 x upper limit of normal (ULN) within 7 days prior to randomization
- •Adequate liver function as measured by serum transaminases (ASAT, ALAT) ≤ 2.5 x ULN and total bilirubin ≤ 1.5 x ULN
- •Adequate renal function with serum creatinine ≤ 1.5 x ULN
- •QTc interval (Bazett**) ≤ 440 ms
排除标准
- •Evidence of metastatic disease (exclusion of distant metastasis by CT of thorax and abdomen, bone scan or MRI [if osseous lesions are suspected due to clinical signs])
- •Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV
- •Clinically significant valvular defect
- •Other severe internal disease or acute infection
- •Peripheral polyneuropathy > NCI Grade II according to CTCAE version 4.03
- •Chronic inflammatory bowel disease
- •Past or current history (within the last 5 years prior to treatment start) of other malignancies. Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible
- •Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 4.03 (see appendix)
- •Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- •Pregnant or lactating females
- •Patients medically unfit for chemotherapy and radiotherapy
- •Patients receiving any immunotherapy, cytotoxic chemotherapy or radiotherapy other than defined by the protocol. The participation in another clinical trial with the use of investigational agents, chemotherapy or radiotherapy during the trial is not permitted
- •Known hypersensitivity against 5-FU, folinic acid, oxaliplatin or docetaxel
- •Other known contraindications against 5-FU, folinic acid, oxaliplatin, or docetaxel
结局指标
主要结局
Progression-free survival (PFS)
Progression-free survival (PFS)
次要结局
- Overall survival, including survival rates after 1, 3 and 5 years
- R0 resection rate
- Number of harvested lymph nodes
- Site of tumor relapse
- Perioperative morbidity and mortality rate
- Safety and toxicity as assessed by NCI CTC criteria
- Quality of life by using the EORTC QLQ-C30 and the esophagogastric module OG25
研究者
Ralf Hofheinz
Scientific
Universitat Heidelberg
研究点 (30)
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