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 sites1,000 target enrollmentApril 8, 2020

Overview

No summary available.

Registry

who.int

Start Date

April 8, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Takemasa Ichiro

•(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

•(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.