JPRN-jRCT1031200006招募中3 期
A Randomized, Phase III Controlled Study to Compare CAPOX Therapy as Post-operative Adjuvant Chemotherapy with Surgery Alone in Patients with Completely Resected Circulating Tumor DNA-negative High-risk Stage II and Low-risk Stage III Colon Cancer - VEGA trial
Takemasa Ichiro0 个研究点目标入组 1,000 人开始时间: 2020年4月8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
- 1,000
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Histopathological diagnosis has been made as primary colonic adenocarcinoma.
- •(2)Based on the operative findings and resected specimen findings, the primary location of the tumor is the colon*. *Includes the rectosigmoid part defined in the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma, Ninth Edition.
- •(3)A colectomy including systematic lymph node dissection of D2 or D3 has been performed.
- •(4)At the time of completion of surgery, residual cancer is considered to be R0.
- •(5)The disease stage based on overall findings is high-risk Stage II (having at least one of the following risk factors (a) to (f) for relapse), or low-risk Stage III (T1-3N1M0) (UICC TNM Classification, 8th Edition).*
- •*N1c (UICC TNM Classification, 8th Edition) is also considered to be eligible (tumor deposits, or satellite nodules, are seen in the adjacent soft tissues of the colon or rectum without subserosal layer or peritoneal coat, but no regional lymph node metastasis)
- •(a)T4 (SE/SI/AI)
- •(b)Intestinal tract obstruction (clinical)
- •(c)Intestinal tract perforation/penetration (clinical)
- •(d)Less than 12 dissected lymph nodes
- •(e)Poorly differentiated adenocarcinoma, signet-ring cell carcinoma, or mucinous carcinoma
- •(f)Positive for lymphatic invasion, venous invasion, or neuroinvasion
- •(6)Negative ctDNA at 28 days+-7 days* post-operatively (the same day of the week as the surgery day is accepted).**
- •*Delays within one week are allowed on public holidays, year-end and New Year holidays, and due to patient visits.
- •**The results of ctDNA testing are based on the test results in the Registry Research in Potentially Surgically Curative Colorectal Cancer.
- •(7)Enrollment can be performed within 8 weeks* after the curative resection and treatment can be started within 2 weeks after the enrollment.
- •*Delays less than three weeks are allowed due to public holidays, year-end and New Year holidays, patient visits, delays in returning ctDNA results, etc.
- •(8)The age at the time of acquisition of informed consent is 20 years or older.
- •(9)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- •(10)No history of chemotherapy, immunotherapy, or radiotherapy within 6 months prior to enrollment, including treatment for other types of cancer.
- •(11)The organ function is met according to the following laboratory values measured within 14 days prior to enrollment (tests performed on the same day of the week 14 days prior to enrollment are acceptable).
- •Neutrophil count:>=1,500 /mm3 (exclude measurement values within 14 days after administration of granulocyte colony-stimulating factor [G-CSF])
- •Platelet count:>=100,000 /mm3
- •Creatinine clearance:>=30 mL/min
- •Total bilirubin:<=2.0 mg/dL
- •AST and ALT:<=100 IU/L
- •CEA:<=10ng/mL
- •(12)Voluntary consent to participation in the study has been obtained.
排除标准
- •(1)There are 2 or more infiltrating cancers of the large intestine origin at the same time. An infiltrating cancer is defined as cancer infiltrating to the submucosa or deeper, and does not include intramucosal cancer.
- •(2)History of a malignant tumor.*
- •*Patients with a relapse-free survival period of 5 years or longer, or patients with basal cell or squamous cell carcinoma of that skin that is considered cured by local treatment, superficial bladder cancer, cervical cancer, carcinoma in situ (intraepithelial cancer) or lesions equivalent to intramucosal cancer, or non-metastatic prostate cancer not requiring systemic treatment may be enrolled.
- •(3)Test using tumor samples shows BRAF V600E mutant type.*( If analysis is not possible, can register)
- •*The results of BRAF testing are based on the test results in the Registry Research in Potentially Surgically Curative Colorectal Cancer.
- •(4)Test using tumor samples shows MSI-H.* (If analysis is not possible, can register)
- •*The results of MSI testing are based on the test results in the Registry Research in Potentially Surgically Curative Colorectal Cancer.
- •(5)Pregnant or breastfeeding women.
- •(6)Patients who do not agree to contraception during treatment and up to 30 days after treatment
- •(7)Patients with complications of uncontrolled infections.
- •(8)Patients with peripheral sensory/motor neuropathy.
- •(9)Patients with complications of uncontrolled diabetes.
- •(10)Patients with complications of uncontrolled congestive heart failure, angina, hypertension, or arrhythmia.
- •(11)Continuous systemic administration of steroids (>= 10 mg/day of prednisolone equivalent) (either oral or IV administration).
- •(12)History or complication of neurologically or mentally significant illness.
- •(13)Positive HBs antigen or positive HCV antibody.
- •(14)Positive HIV antibody (a patient may enroll even if HIV antibody has not been tested).
- •(15)Known deficiency of dihydoropyrimidine dehydrogenase (DPD).
- •(16)History of allergy to oxaliplatin and/or capecitabine.
- •(17) There is an active new corona infection (COVID-19)*.
- •* Known SARS-CoV-2 PCR positive patients or patients with suspected COVID-19 due to clinical symptoms. Patients with negative SARS-CoV-2 PCR and no COVID-19 symptoms can be enrolled, but excluded if the attending physician determines that it will affect the evaluation of this study (COVID -19 inspection is not mandatory).
- •(18)Any other cases which are judged to be inappropriate for participation in this clinical study by a physician.
研究者
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