JPRN-jRCTs031230415招募中3 期
JCOG2207: A phase III randomized controlled trial comparing total mesorectal excision and lateral lymph node dissection plus adjuvant chemotherapy with total neoadjuvant therapy followed by total mesorectal excision and selective lateral lymph node dissection for the patients with locoregionally advanced low rectal cancer - MARIAGE
OHUE Masayuki0 个研究点目标入组 420 人开始时间: 2023年10月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
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
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Endoscopic biopsy from a primary rectal lesion has been histologically diagnosed as adenocarcinoma, (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, medullary carcinoma) or adenosqamous cell carcinoma. Or endoscopic biopsy from a primary lesion in the anal canal has been histologically diagnosed as adenocarcinoma (rectal type) or adenosquamous cell carcinoma.
- •(2) The tumor is predominantly located in the upper rectum (Ra), lower rectum (Rb), or anal canal (P).
- •(3) The lower margin of the tumor is located between the perineal reflection and the anal verge (Rb-P).
- •(4) Comprehensive diagnosis of cT2-cT4b by abdominal and pelvic contrast CT and pelvic contrast MRI. Among cT4b, cases with suspected organ infiltration of one or more of the following are excluded.
- •(a) Trigone of bladder, (b) urethra, (c) sacrum.
- •(5) Lymph node satisfying either (i) or (ii) below is present on comprehensive diagnosis by contrast CT of the chest, abdomen, and pelvic region with a slice thickness of 1.25 mm or less and contrast MRI of the pelvic region with a slice thickness of 5mm or less.
- •(i) 10 mm or more in short diameter
- •(ii) 7 mm or more in short diameter and one or mor e of the following (a)-(c).
- •(a) Irregular margins
- •(b) MRI shows internal inhomogeneous low-signal areas
- •(c) Circular (long to short diameter ratio < 1.5)
- •(6) No distant metastasis on chest CT and contrast abdominal/pelvic CT (cM0).
- •(7) Comprehensive diagnosis using colonoscopy and imaging studies (barium enema, abdominal/pelvic contrast CT, or CT colonography) does not reveal multiple carcinomas. However, cTis and cT1a (cancer is expected to remain in the submucosal layer and invade less than 1,000 micrometre) lesions that are expected to be curatively resectable by endoscopic resection are not considered multiple carcinomas.
- •(8) Patients must be between 18 and 75 years of age on the date of enrollment.
- •(9) Performance status (PS) is 0 or 1 according to ECOG criteria
- •(10) The patient is able to take oral intake.
- •(11) The patient has not undergone rectal resection (except for endoscopic resection), radiation therapy to the pelvic region, or any previous treatment , including treatment for other types of cancer.
- •(12) The most recent laboratory values within 14 days prior to enrollment (the same day of the week two weeks prior to the date of enrollment is accept able) meet all of the following
- •1. Neutrophil count >= 1,500/mm3
- •3. Platelet count >= 100,000/mm3
- •4. Total bilirubin <= 2.0 mg/dL
- •5. AST <= 100 U/L
- •6. ALT <= 100 U/L
- •7. Serum creatinine <= 1.5 mg/dL
- •8. Creatinine clearance >= 30 mL/min
- •(13) Written consent to participate in the study has been obtained from the patient.
排除标准
- •(1) Active multiple cancers (simultaneous multiple cancers and multiple cancers with a disease-free interval of 5 years or less. However, multiple cancers do not include stage I prostate cancer, stage 0 or stage I laryngeal cancer that has had a complete response to radiotherapy, or cancer that has been completely resected with a 5-year relative survival rate equivalent to 95% or greater).
- •(2) Infectious diseases requiring systemic treatment.
- •(3) Have a fever of 38.0 degrees Celsius or higher at the time of registration.
- •(4) Pregnant, possibly pregnant, within 28 days po stpartum, or lactating. Males whose partners wish to become pregnant. Female who wish to become pregnant in the future. Female who cannot tolerate early menopause with radiation therapy.
- •(5) Patients with psychiatric disorders or psychiatric symptoms that interfere with daily life and make it difficult for them to participate in the study.
- •(6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
- •(7) Complicated with poorly controlled diabetes mellitus.
- •(8) Patient has uncontrolled hypertension.
- •(9) Complicated with unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within the last 6 months.
- •(10) Poorly controlled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- •(11) HBs antigen positive.
- •(12) HIV antibody positive.
- •(13) Has one or more of the following complications diagnosed by chest CT: interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
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