The Sixth Affiliate Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Location status: Recruiting
Location contact
Shaoyong Peng, MD
CONTACT
Yanxin Luo, PhD,MD
CONTACT
NCT Number: NCT03587480
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, China
Location status: Recruiting
Shaoyong Peng, MD
CONTACT
Yanxin Luo, PhD,MD
CONTACT
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tumor invade other organs Lower tumor margin is above the peritoneal reflection
patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)
Time frame: 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
36 months after surgery
Time frame: Operation day
Operation day
Time frame: Operation day
in the perioperative period
Time frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
Time frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
Time frame: 3 years
From the date of operation until the date of complication,assessed up to 3 years
Time frame: 3 months
From the date of operation until the date of complication,assessed up to 3 months
Time frame: From the date of operation until the date of death,assessed up to 5 years
60 months after surgery
Time frame: From date of operation until the date of local-recurrence (up to 3 years)
36 months after surgery
Time frame: 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
60 months after surgery
Time frame: 3 months after operation
The study investigate the quality of life using the WHOQOL Scale
Contact information is provided by the study sponsor or research team.
Shaoyong Peng
CONTACT
Yanxin Luo
CONTACT
Sixth Affiliated Hospital, Sun Yat-sen University
Other
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
Acronym: TELEPHOME
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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