Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063288) titled 'Prospective Cohort Study to Clarify the clinical benefit of lateral Pelvic Lymph node Dissection in Low Rectal Cancer' on Oct. 15.

Study Type: Observational

Primary Sponsor: Institute - Japanese Society for Cancer of the Colon and Rectum (JSCCR)

Condition: Condition - Rectal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the clinical benefit of lateral pelvic lymph node dissection (LLND) and reconsider the optimal patient population and dissection extent in low rectal cancer patients undergoing rectal resection with LLND. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1.Histologically confirmed adenocarcinoma (including mucinous carcinoma and signet-ring cell carcinoma) according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma (9th edition) by preoperative endoscopic biopsy of the primary colorectal lesion

2.Primary tumor located in the low rectum or anal canal, or the lower border of the tumor located in the low rectum, meeting at least one of the following: Depth of tumor invasion is clinical T2 or deeper Lateral pelvic lymph node metastasis is suspected on preoperative imaging (evaluated according to institutional criteria) Mesorectal lymph node metastasis is suspected on preoperative imaging (evaluated according to institutional criteria)

3.No prior chemotherapy or radiotherapy for rectal cancer

4.Scheduled for primary rectal resection combined with bilateral lateral pelvic lymph node dissection (open, laparoscopic, or robotic approaches are all permitted)

5.No prior history of surgery, chemotherapy, or radiotherapy for pelvic tumors (e.g., rectal cancer, gynecological malignancies, urological malignancies)

6.No multiple cancers on preoperative imaging, and absence of distant organ metastasis, distant lymph node metastasis, and peritoneal dissemination (not cStage IV)

7.Age 20 to 79 years at enrollment

8.Written informed consent obtained from the patient Key exclusion criteria - 1.Patients who do not provide written informed consent 2.Patients judged unsuitable for study participation by the attending physician Target Size - 840

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2019 Year 02 Month 14 Day Date of IRB - 2019 Year 01 Month 17 Day Anticipated trial start date - 2019 Year 03 Month 01 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072413

Disclaimer: Curated by HT Syndication.