MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850027
• Other study ID #: MALAREC
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2021
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qian Liu, M.D
• Phone: 01087787110
• Email: fcwpumch[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Description:

Our study design is a multicenter, prospective, registry study.

We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.

The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 ~ 50.5 Gy are recommended.

The postoperative examination should be performed every three months in the first two years and every six months in the following three years.

Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18-75 years old

2. Pathologically confirmed as rectal adenocarcinoma

3. The tumor is located in the middle or lower rectum

4. Preoperative MRI assessment is T2-4 N+M0

5. Lateral lymph node short diameter = 5 mm (MRI)

6. Signed informed consent

Exclusion Criteria:

1. Previous history of malignant colorectal tumors

2. Multiple abdominal or pelvic surgeries were performed

3. Complicated with bowel obstruction, perforation or bleeding

4. Patients undergoing palliative surgery

5. Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery

6. Have a history of severe mental illness

7. Pregnant or breastfeeding women (8) Patients previously treated with iliac artery surgery (or its branches)

(9) R0 resection cannot complete (10) ASA grade = IV

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• TME+Lateral lymph node dissection.
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter = 5 mm.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College	Beijing	Beijing

Sponsors (22)

Lead Sponsor

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing Cancer Hospital, Beijing Friendship Hospital, China-Japan Friendship Hospital, China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Hospital of China Medical University, Peking Union Medical College Hospital, Peking University First Hospital, Ruijin Hospital, Second Affiliated Hospital of Suzhou University, Shanghai Cancer Hospital, China, Shengjing Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Hospital of Qingdao University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Dalian Medical University, The First Hospital of Jilin University, Tianjin People's Hospital, West China Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Akiyoshi T, Ueno M, Matsueda K, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Unno T, Kano A, Kuroyanagi H, Oya M, Yamaguchi T, Watanabe T, Muto T. Selective lateral pelvic lymph node dissection in patients with advanced low rectal cancer treated with preoperative chemoradiotherapy based on pretreatment imaging. Ann Surg Oncol. 2014 Jan;21(1):189-96. doi: 10.1245/s10434-013-3216-y. Epub 2013 Aug 21. — View Citation

Baik SH, Kim NK, Lee YC, Kim H, Lee KY, Sohn SK, Cho CH. Prognostic significance of circumferential resection margin following total mesorectal excision and adjuvant chemoradiotherapy in patients with rectal cancer. Ann Surg Oncol. 2007 Feb;14(2):462-9. Epub 2006 Nov 10. — View Citation

Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212. — View Citation

Furuhata T, Okita K, Nishidate T, Ito T, Yamaguchi H, Ueki T, Akizuki E, Meguro M, Ogawa T, Kukita K, Kimura Y, Mizuguchi T, Hirata K. Clinical feasibility of laparoscopic lateral pelvic lymph node dissection following total mesorectal excision for advanced rectal cancer. Surg Today. 2015 Mar;45(3):310-4. doi: 10.1007/s00595-014-0906-4. Epub 2014 May 3. — View Citation

Ishihara S, Kawai K, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Morikawa T, Watanabe T. Oncological Outcomes of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer Treated With Preoperative Chemoradiotherapy. Dis Colon Rectum. 2017 May;60(5):469-476. doi: 10.1097/DCR.0000000000000752. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological positive rate	The proportion of patients with positive lateral lymph node which was confirmed pathologically.	3-year.
Primary	Local recurrence rate	The proportion of patients with local recurrence after 3 years of surgery	3-year
Primary	Overall survival rate	The proportion of patients survived after 3 years of surgery	3-year
Primary	Disease free survival	The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.	3-year
Secondary	Early morbidity rate	The early morbidity rate is defined as the event observed during operation and within 30 days after surgery	30 days
Secondary	Duration of the surgery	The duration of time between the start and the end of the surgery.	1 day
Secondary	Postoperative complications	Complications occurring within 30 days after surgery, mainly urinary and sexual functions.	30 days