Clinical trial NCT06986538: Extent of Lymph Node Dissection for Advanced Right-Sided Colon Cance
Official title: A Multicenter Randomized Controlled Study of the Extent of Lymph Node Dissection for Advanced Right-sided Colon Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Right-sided Colon Cancer
the Extent of Lymph Node Dissection
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective multicenter randomized controlled clinical study to explore the extent of lymph node dissection in progressive right hemicolon cancer and to elucidate the pattern of lymphatic drainage in the right hemicolon.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-75 years
2. Preoperative pathologic confirmation of adenocarcinoma
3. Tumor located in the region from the ileocecal valve to the right one-third of the transverse colon
4. American Society of Anesthesiologists (ASA) physical status classification I to III
5. Patients who have not received preoperative radiotherapy, chemotherapy, or immunotherapy
6. Preoperative imaging staging cT4N0M0 or cT3-4N+M0
7. Willing to participate in the study and sign the informed consent form

Exclusion Criteria:

1. Past medical history of malignant tumor
2. Patients with multiple primary tumors
3. Patients with a history of inflammatory bowel disease or familial adenomatous polyposis
4. Patients with distant metastasis
5. Pregnant or breastfeeding women
6. History of other previous major abdominal surgery
7. Patients requiring emergency surgery (including tumor perforation, obstruction, hemorrhage, etc.)
8. Those with other clinical and laboratory conditions deemed by the investigator to be inappropriate for participation in the trial

Primary outcomes:
measure: Disease-Free Survival
timeFrame: The third postoperative year
Secondary outcomes:
measure: overall survival
timeFrame: The third postoperative year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academyof Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Affiliated Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Department of Coloretcal Surgery, the Sixth Affiliated Hospital of Sun Yat-sen University,
state: Guangdong
city: Qingyuan
country: China
facility: Qingyuan People's Hospital
state: Guangdong
city: Shaoguan
country: China
facility: Yuebei People's Hospital
state: Guangdong
city: Zhaoqing
country: China
facility: Zhaoqing First People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospita
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospitalof Naval Medical University
state: Shanghai
city: Xian
country: China
facility: Shaanxi ProvincialPeople's Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Wenzhou
country: China
facility: The First Affiliated Hospital of WenzhouMedical University
state: Zhejiang
Study officials:
References: