Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy

Rectal Neoplasm Malignant Clinical Trial

— TELEPHOME  

Official title:

Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy of Lower Rectal Cancer With Suspected Local Lymph Node Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03587480
• Other study ID #: Luo-20180624
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: May 24, 2030

Study information

• Verified date: March 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Yanxin Luo
• Phone: 020-38250745
• Email: luoyx25[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment for Low rectal cancer, especially in patients with regional lymph node metastasis are quite different between Japanese guideline (JSCCR) and western countries' guideline (NCCN, ESMO). While Japanese scholars advocate total mesorectal excision (TME) plus lateral lymph node dissection (LLND), European and American scholars advocate TME alone after Neoadjuvant Chemo-radiotherapy (nCRT), without the need of LLND. Accordingly, this clinical trial is designed to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. It will provide high-level clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Description:

There are significant differences between Japanese guidelines (JSCCR) and Western guidelines (NCCN, ESMO) in the treatment of low rectal cancer, especially in patients with regional lymph node metastasis. Japanese scholars advocated total meso rectal resection (TME) + Lateral lymph node dissection (LLND), However, European and American scholars advocate that only TME is used after new adjuvant chemo-radiation (nCRT), without LLND. Therefore, the purpose of this clinical trial was to directly compare the efficacy and safety of these two treatment strategies for low rectal cancer with regional lymph node metastasis. This will provide a high level of clinical evidence for the treatment of low rectal cancer with suspected local lymph node metastasis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 24, 2030
• Est. primary completion date: May 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage ?

2. Tumor is capable of performing radical recession

3. No past history of chemotherapy, pelvic radiation of other cancers.

4. Written informed consent

5. Lower tumor margin is confirmed below the peritoneal reflection

6. Clinical state T(1-3)N(1-2)M0 is confirmed by the multiple disciplines team(MDT) including surgeons,diagnostic radiologist,radiation oncologist and medical oncologists base on MRI and endorectal ultrasound -

Exclusion Criteria:

1. Past history of other cancers

2. Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)

3. Combine with inflammatory bowl disease(IBD)

4. Recurrence tumor or invade other organs

5. Combine with obstruction,perforation or bleeding which need emergency surgery.

6. Local tumor invade the external sphincter, levator ani muscle or adjacent organs

7. Participant join other clinical trials in 4 weeks.

8. American Society of Anesthesiologists(ASA) =? and/or Eastern Cooperative Oncology Group(ECOG) =2

9. Pregnant or lactating patients

10. Severity infection before operation

11. Psychological disorder

12. Severe dysfunction of organs or other contraindications

13. Cardiac infarction within six months

14. Severe pulmonary emphysema and pulmonary fibrosis

15. Doctor's decision for exclusion

16. Operative findings:

Tumor invade other organs Lower tumor margin is above the peritoneal reflection

Related Conditions & MeSH terms

• Neoplasms
• Rectal Neoplasm Malignant
• Rectal Neoplasms

Intervention

Procedure:
• TME+LLND
patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
• TME+nCRT
patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)

Locations

Country	Name	City	State
China	The Sixth Affiliate Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (9)

Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. doi: 10.1200/JCO.2016.66.6198. Epub 2016 Aug 1. — View Citation

Fujita S, Akasu T, Mizusawa J, Saito N, Kinugasa Y, Kanemitsu Y, Ohue M, Fujii S, Shiozawa M, Yamaguchi T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Postoperative morbidity and mortality after mesorectal excision with and w — 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 Jap — View Citation

Huang M, Lin J, Yu X, Chen S, Kang L, Deng Y, Zheng J, Luo Y, Wang L, Lan P, Wang J. Erectile and urinary function in men with rectal cancer treated by neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy alone: a randomized trial report. Int J Colorectal Dis. 2016 Jul;31(7):1349-57. doi: 10.1007/s00384-016-2605-7. Epub 2016 Jun 6. — View Citation

Ito M, Kobayashi A, Fujita S, Mizusawa J, Kanemitsu Y, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Urinary dysfunction after rectal cancer surgery: Results from a randomized trial comparing mesorectal excision with and without lateral lymph node dissection for clinical stage II or III lower rectal cancer (Japan Clinical Oncology Group Study, JCOG0212). Eur J Surg Oncol. 2018 Apr;44(4):463-468. doi: 10.1016/j.ejso.2018.01.015. Epub 2018 Jan 17. — View Citation

Nagawa H, Muto T, Sunouchi K, Higuchi Y, Tsurita G, Watanabe T, Sawada T. Randomized, controlled trial of lateral node dissection vs. nerve-preserving resection in patients with rectal cancer after preoperative radiotherapy. Dis Colon Rectum. 2001 Sep;44( — View Citation

Ogura A, Akiyoshi T, Nagasaki T, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Ueno M, Kuroyanagi H. Feasibility of Laparoscopic Total Mesorectal Excision with Extended Lateral Pelvic Lymph Node Dissection for Advanced Lower Rectal Cancer after Preoperat — View Citation

Qin Q, Ma T, Deng Y, Zheng J, Zhou Z, Wang H, Wang L, Wang J. Impact of Preoperative Radiotherapy on Anastomotic Leakage and Stenosis After Rectal Cancer Resection: Post Hoc Analysis of a Randomized Controlled Trial. Dis Colon Rectum. 2016 Oct;59(10):934-42. doi: 10.1097/DCR.0000000000000665. — View Citation

Shinagawa T, Tanaka T, Nozawa H, Emoto S, Murono K, Kaneko M, Sasaki K, Otani K, Nishikawa T, Hata K, Kawai K, Watanabe T. Comparison of the guidelines for colorectal cancer in Japan, the USA and Europe. Ann Gastroenterol Surg. 2017 Dec 19;2(1):6-12. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival	36 months after surgery	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary	Operative time	Operation day	Operation day
Secondary	Blood loss	in the perioperative period	Operation day
Secondary	Incidence of sexual dysfunction	From the date of operation until the date of complication,assessed up to 3 years	3 years
Secondary	Incidence of urinary dysfunction	From the date of operation until the date of complication,assessed up to 3 years	3 years
Secondary	Incidence of defecation dysfunction	From the date of operation until the date of complication,assessed up to 3 years	3 years
Secondary	incidence of Postoperative complications	From the date of operation until the date of complication,assessed up to 3 months	3 months
Secondary	overall survival	60 months after surgery	From the date of operation until the date of death,assessed up to 5 years
Secondary	3-year local recurrence rate	36 months after surgery	From date of operation until the date of local-recurrence (up to 3 years)
Secondary	5-year disease-free survival	60 months after surgery	From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Secondary	the score of quality of life	The study investigate the quality of life using the WHOQOL Scale	3 months after operation