KCT0007169招募中未知
Total neoadjuvant therapy with short-course radiotherapy versus long-course neoadjuvant chemoradiotherapy in locally advanced rectal cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •(1) Histologically diagnosed locally advanced rectal cancer (stage II/III)
- •(2) The distal border of the tumor located =10 cm from the anal verge
- •(3) Men and women aged 19-80 years
- •(4) No evidence of distant metastasis (including paraaortic LN, common & external iliac LN) on abdominal pelvic CT or chest CT scan
- •(5) ECOG performance =1 and be capable of activities for daily living
- •(6) American Society of Anesthesiologists (ASA) Physical Status Classification System Class I~II
- •(7) No history of any other systemic treatment (chemotherapy, immunotherapy) or radiotherapy for rectal cancer
- •(8) No history of intrapelvic radiotherapy
- •(9)The following investigation criteria should be satisfied:
- •Bone marrow function: absolute neutrophils =1,500/mm3, platelets =75,000/mm3
- •Liver function: bilirubin =2.0 X upper limit of normal, liver function enzymes level (AST/ALT) =2.5 X upper limit of normal
- •Renal function: creatinine =1.5 X upper limit of normal or renal filtration rate (Ccr, calculated using Cockcroft formula) =50 ml/min
- •(10) Patients who can comply with the study protocol for the duration of the study
- •(11) Patients who understand the study process and treatment plan and have signed the informed consent
排除标准
- •(1) Histological carcinoma other than rectal adenocarcinoma or adenocarcinoma arising from inflammatory bowel disease
- •(2) Suspected distant metastasis
- •(3) NCI CTC grade 1 or higher peripheral neuropathy
- •(4) Uncontrolled or severe cardiovascular disease, myocardial infarction within 6 months, NYHA grade 3 or higher heart failure, or uncontrolled angina
- •(5) Infection or other disease that is not currently controlled
- •(6) History of other malignancies within 5 years (except for cured superficial skin cancer or cervical carcinoma in situ)
- •(7) History of organ transplant requiring immunosuppressive therapy
- •(8) Uncontrolled epilepsy or psychosis
- •(9) Pregnant or lactating women, women of childbearing potential who do not intend to actively use contraception, or men who are planning pregnancy or do not intend to actively use contraception
- •(10) Cases required to continue concomitant treatment expected to interact with oxaliplatin, such as flucytosine, phenytoin, or warfarin
- •(11) Previous hypersensitivity to fluoropyrimidine agents or confirmed DPD deficiency
- •(12) Patients on tegafur, gimeracil, or oteracil potassium combinations or those who have stopped the administration of those drugs within 7 days
- •(13) Patients on sorivudine or brivudine
- •(14) Hypersensitivity to platinum, leucovorin, or capecitabine
- •(15) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •(16) Participation in other clinical study within 4 weeks prior to the start of the study
- •(17) Patients treated with bevacizumab, cetuximab, oxaliplatin, or irinotecan prior to surgery
研究者
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