Rectal CancerNCT02614157
Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer
A study testing LLND and labeled line in people with Rectal Cancer, run by West China Hospital at 1 site in China.
Trial summary
Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- LLND and labeled line
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed rectal cancer (below the peritoneal reflection) Clinical stage I, II, or III
- No extramesorectal lymph node swelling (shorter diameter is less than 10 mm)
- No invasion to other organ (s)
- PS: 0, 1
- No past history of chemotherapy, pelvic surgery or radiation
- Written informed consent operative criteria:
Show all 11Show fewer
- Mesorectal excision is performed
- Operative findings:
- Main lesion of the tumor is located at the rectum
- Lower tumor margin is below the peritoneal reflection
- R0 after resection
Who cannot join
- High rectal cancer
- Multiple cancer patients
- Pregnant patients
- Psychological disorder
- Steroid administration
- Cardiac infarction within six months
- Severe pulmonary emphysema and pulmonary fibrosis
- Doctor's decision for exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Pelvic Lymph Node Dissection After Neoadjuvant Chemo-radiation for Preoperative Enlarged Lateral Nodes in Advanced Low Rectal Cancer: a Phase III Randomized Controlled Trial
Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on the contrary. Existing reports tend to recommend LLND for specific individual with suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.
Read the detailed description
Recently, the incidence and mortality of colorectal cancer have increased, leading the second prevalence after lung cancer. Local recurrence of mid/low rectal cancer is not only the poor prognostic factor but also the threat of terrible quality of life. Although universal usage of neoadjuvant chemo-radiotherapy (nCRT) and total mesorectal excision (TME) have decreased local recurrence to 5%-10%, the ratio of local recurrence has occupied almost 30% of total metastasis and recurrence incidences, which limited the therapeutic effect of rectal cancer. Increasing evidences have demonstrated lateral pelvic lymph nodes (LLN) metastasis as one of the prominent causes of local recurrence, accompanied with 10%-25% advanced rectal cancer. Published researches also reminder us preoperative LLN involvement may lead to high local recurrence and poor overall survival.
As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) or LLND+TME after nCRT:
Eastern countries especially Japan favors LLND following TME with the reasons: 1) the incidence of LLN metastasis reaches as high as 10%-25% and 27% of rectal patients who undergo TME solely (without LLND) will develop into local recurrence. And the predictive pelvic recurrence rate will decrease 50%; corresponding 5-year overall survival will increase 8%-9%. 2) efficacy of LLND equals to resection of "local lymph nodes metastases". A large cohort of 11567 cases from Japan demonstrates resection of iliac lymph nodes metastasis does not show any difference from TME of cTxN2aM0 and resection of obturator and external iliac lymph nodes favors that of liver metastasis. 3) Japanese Guidelines for treatment of colorectal in 2014 also recommends mid/low II/III rectal cancer under peritoneal reflex undergo regular TME+LLND.
On the contrary, western countries favor sole TME after nCRT for LLN metastasis, holding that: 1) rate of lymph nodes metastasis is relatively low and LLN metastasis is regarded as systemic metastasis. 2) LLND experiences longer operative time, higher postoperative complications, and poor quality of life. 3) American NCCN and European ESMO guidelines recommend single TME for rectal cancer, if necessary, LLDN is added when LLN is indeed metastasis.
However, there is a blank strict prospective randomized control study on the comparison of nCRT and LLND. Present existing retrospective cohort mainly focus on all the mid/low advanced cancer, not the specific individual of suspicious LLN metastasis. In fact, the results almost indicate no differences on local recurrence and overall survival, except for less operation time, blood loss, and perioperative complications in LLND. Although the latest researches start to report their preliminary outcomes, the patients sample sizes are small and they achieve varied recurrence and overall survival.
In conclusion, the treatment strategy for colorectal cancer has focused on individual and precision. Massive of retrospective reports have indicated that rectal cancer patients with LLN metastasis will benefit from LLND, however, there is hot controversy on the treatment of whether TME+LLND or TME+nCRT for specific rectal patients with suspicious LLN metastasis. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.
- Conditions
- Rectal Cancer
- Being tested
- LLND, labeled line
- Keywords
- rectal cancer, lateral lymph node dissection, neoadjuvant chemoradiation, total mesorectal excision, surgery, recurrence, metastasis, overall survival
- Medical subject headings
- Rectal Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLNDProcedure or surgery
Also called Lateral Lymph Node Dissection
advanced rectal cancer patients whose lymph nodes are suspiciously enlarged after neoadjuvant chemoradiation will undergo lateral lymph node dissection (LLND) and total mesorectal excision (TME)
labeled lineDevice
| Study group | Role | What they receive |
|---|---|---|
| LLND+TME group | Experimental | advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo lateral lymph node dissection and total mesorectal excision(LLND+TME) Receives: Procedure: LLND; Device: labeled line |
| TME group | No intervention | advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo total mesorectal excision (TME)solely, without LLND |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year local recurrence
Measured: until local-recurrence (up to 3 years)
Secondary outcomes (4)
overall survival
Measured: 3 years
disease free survival
Measured: 3 years
Incidence of sexual and urinary dysfunction
Measured: 1 year
postoperative complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: The enrollment was too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziqiang Wang,MD, West China Hospital
- Investigators
- Ziqiang Wang, MD,PhD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614157
- Sponsor's protocol ID
- pLNR-201501
- Status last verified
- Jun 2016
- First submitted
- 23 Nov 2015
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
PubMed 17096053Quadros CA, Falcao MF, Carvalho ME, Ladeia PA, Lopes A. Metastases to retroperitoneal or lateral pelvic lymph nodes indicated unfavorable survival and high pelvic recurrence rates in a cohort of 102 patients with low rectal adenocarcinoma. J Surg Oncol. 2012 Nov;106(6):653-8. doi: 10.1002/jso.23144. Epub 2012 Apr 25.
PubMed 22535617Ueno M, Oya M, Azekura K, Yamaguchi T, Muto T. Incidence and prognostic significance of lateral lymph node metastasis in patients with advanced low rectal cancer. Br J Surg. 2005 Jun;92(6):756-63. doi: 10.1002/bjs.4975.
PubMed 15838895Yano H, Moran BJ. The incidence of lateral pelvic side-wall nodal involvement in low rectal cancer may be similar in Japan and the West. Br J Surg. 2008 Jan;95(1):33-49. doi: 10.1002/bjs.6061.
PubMed 18165939Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.
PubMed 11547717Kusters M, Marijnen CA, van de Velde CJ, Rutten HJ, Lahaye MJ, Kim JH, Beets-Tan RG, Beets GL. Patterns of local recurrence in rectal cancer; a study of the Dutch TME trial. Eur J Surg Oncol. 2010 May;36(5):470-6. doi: 10.1016/j.ejso.2009.11.011. Epub 2010 Jan 21.
PubMed 20096534Nagawa 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(9):1274-80. doi: 10.1007/BF02234784.
PubMed 11584199Ueno H, Mochizuki H, Hashiguchi Y, Ishiguro M, Miyoshi M, Kajiwara Y, Sato T, Shimazaki H, Hase K. Potential prognostic benefit of lateral pelvic node dissection for rectal cancer located below the peritoneal reflection. Ann Surg. 2007 Jan;245(1):80-7. doi: 10.1097/01.sla.0000225359.72553.8c.
PubMed 17197969Watanabe T, Tsurita G, Muto T, Sawada T, Sunouchi K, Higuchi Y, Komuro Y, Kanazawa T, Iijima T, Miyaki M, Nagawa H. Extended lymphadenectomy and preoperative radiotherapy for lower rectal cancers. Surgery. 2002 Jul;132(1):27-33. doi: 10.1067/msy.2002.125357.
PubMed 12110792Yano H, Saito Y, Takeshita E, Miyake O, Ishizuka N. Prediction of lateral pelvic node involvement in low rectal cancer by conventional computed tomography. Br J Surg. 2007 Aug;94(8):1014-9. doi: 10.1002/bjs.5665.
PubMed 17436337Georgiou P, Tan E, Gouvas N, Antoniou A, Brown G, Nicholls RJ, Tekkis P. Extended lymphadenectomy versus conventional surgery for rectal cancer: a meta-analysis. Lancet Oncol. 2009 Nov;10(11):1053-62. doi: 10.1016/S1470-2045(09)70224-4. Epub 2009 Sep 18.
PubMed 19767239Kim JC, Takahashi K, Yu CS, Kim HC, Kim TW, Ryu MH, Kim JH, Mori T. Comparative outcome between chemoradiotherapy and lateral pelvic lymph node dissection following total mesorectal excision in rectal cancer. Ann Surg. 2007 Nov;246(5):754-62. doi: 10.1097/SLA.0b013e318070d587.
PubMed 17968166Suzuki K, Muto T, Sawada T. Prevention of local recurrence by extended lymphadenectomy for rectal cancer. Surg Today. 1995;25(9):795-801. doi: 10.1007/BF00311455.
PubMed 8555697Sato H, Maeda K, Maruta M, Masumori K, Koide Y. Who can get the beneficial effect from lateral lymph node dissection for Dukes C rectal carcinoma below the peritoneal reflection? Dis Colon Rectum. 2006 Oct;49(10 Suppl):S3-12. doi: 10.1007/s10350-006-0699-7.
PubMed 17106812Kim TH, Jeong SY, Choi DH, Kim DY, Jung KH, Moon SH, Chang HJ, Lim SB, Choi HS, Park JG. Lateral lymph node metastasis is a major cause of locoregional recurrence in rectal cancer treated with preoperative chemoradiotherapy and curative resection. Ann Surg Oncol. 2008 Mar;15(3):729-37. doi: 10.1245/s10434-007-9696-x. Epub 2007 Dec 5.
PubMed 18057989
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Pelvic Lymph Node Dissection After Neoadjuvant Chemo-radiation for Preoperative Enlarged Lateral Nodes in Advanced Low Rectal Cancer: a Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02614157
- Acronym / sponsor ID
- pLNR-201501
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, lateral lymph node dissection, neoadjuvant chemoradiation, total mesorectal excision, surgery, recurrence, metastasis, overall survival
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment was too low
- Enrolment
- 51 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on the contrary. Existing reports tend to recommend LLND for specific individual with suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.
Detailed description
Recently, the incidence and mortality of colorectal cancer have increased, leading the second prevalence after lung cancer. Local recurrence of mid/low rectal cancer is not only the poor prognostic factor but also the threat of terrible quality of life. Although universal usage of neoadjuvant chemo-radiotherapy (nCRT) and total mesorectal excision (TME) have decreased local recurrence to 5%-10%, the ratio of local recurrence has occupied almost 30% of total metastasis and recurrence incidences, which limited the therapeutic effect of rectal cancer. Increasing evidences have demonstrated lateral pelvic lymph nodes (LLN) metastasis as one of the prominent causes of local recurrence, accompanied with 10%-25% advanced rectal cancer. Published researches also reminder us preoperative LLN involvement may lead to high local recurrence and poor overall survival.
As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) or LLND+TME after nCRT:
Eastern countries especially Japan favors LLND following TME with the reasons: 1) the incidence of LLN metastasis reaches as high as 10%-25% and 27% of rectal patients who undergo TME solely (without LLND) will develop into local recurrence. And the predictive pelvic recurrence rate will decrease 50%; corresponding 5-year overall survival will increase 8%-9%. 2) efficacy of LLND equals to resection of "local lymph nodes metastases". A large cohort of 11567 cases from Japan demonstrates resection of iliac lymph nodes metastasis does not show any difference from TME of cTxN2aM0 and resection of obturator and external iliac lymph nodes favors that of liver metastasis. 3) Japanese Guidelines for treatment of colorectal in 2014 also recommends mid/low II/III rectal cancer under peritoneal reflex undergo regular TME+LLND.
On the contrary, western countries favor sole TME after nCRT for LLN metastasis, holding that: 1) rate of lymph nodes metastasis is relatively low and LLN metastasis is regarded as systemic metastasis. 2) LLND experiences longer operative time, higher postoperative complications, and poor quality of life. 3) American NCCN and European ESMO guidelines recommend single TME for rectal cancer, if necessary, LLDN is added when LLN is indeed metastasis.
However, there is a blank strict prospective randomized control study on the comparison of nCRT and LLND. Present existing retrospective cohort mainly focus on all the mid/low advanced cancer, not the specific individual of suspicious LLN metastasis. In fact, the results almost indicate no differences on local recurrence and overall survival, except for less operation time, blood loss, and perioperative complications in LLND. Although the latest researches start to report their preliminary outcomes, the patients sample sizes are small and they achieve varied recurrence and overall survival.
In conclusion, the treatment strategy for colorectal cancer has focused on individual and precision. Massive of retrospective reports have indicated that rectal cancer patients with LLN metastasis will benefit from LLND, however, there is hot controversy on the treatment of whether TME+LLND or TME+nCRT for specific rectal patients with suspicious LLN metastasis. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLND+TME group | Experimental | Procedure: LLND, Device: labeled lineadvanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo lateral lymph node dissection and total mesorectal excision(LLND+TME) |
| TME group | No intervention | –advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo total mesorectal excision (TME)solely, without LLND |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed rectal cancer (below the peritoneal reflection) Clinical stage I, II, or III
- No extramesorectal lymph node swelling (shorter diameter is less than 10 mm)
- No invasion to other organ (s)
- PS: 0, 1
- No past history of chemotherapy, pelvic surgery or radiation
Key exclusion criteria (8 listed)
- High rectal cancer
- Multiple cancer patients
- Pregnant patients
- Psychological disorder
- Steroid administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLNDAlso: Lateral Lymph Node Dissectionadvanced rectal cancer patients whose lymph nodes are suspiciously enlarged after neoadjuvant chemoradiation will undergo lateral lymph node dissection (LLND) and total mesorectal excision (TME) | Procedure or surgery | LLND+TME group |
| labeled line | Device | LLND+TME group |
Primary outcome
3-year local recurrence
Time frame: until local-recurrence (up to 3 years)
4 secondary outcomes
overall survival
Time frame: 3 years
disease free survival
Time frame: 3 years
Incidence of sexual and urinary dysfunction
Time frame: 1 year
postoperative complications
Time frame: 1 year
Results and safety
The study was stopped early (reason given: The enrollment was too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Background: PubMed 17096053Baik 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. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
- Background: PubMed 22535617Quadros CA, Falcao MF, Carvalho ME, Ladeia PA, Lopes A. Metastases to retroperitoneal or lateral pelvic lymph nodes indicated unfavorable survival and high pelvic recurrence rates in a cohort of 102 patients with low rectal adenocarcinoma. J Surg Oncol. 2012 Nov;106(6):653-8. doi: 10.1002/jso.23144. Epub 2012 Apr 25.
- Background: PubMed 15838895Ueno M, Oya M, Azekura K, Yamaguchi T, Muto T. Incidence and prognostic significance of lateral lymph node metastasis in patients with advanced low rectal cancer. Br J Surg. 2005 Jun;92(6):756-63. doi: 10.1002/bjs.4975.
- Background: PubMed 18165939Yano H, Moran BJ. The incidence of lateral pelvic side-wall nodal involvement in low rectal cancer may be similar in Japan and the West. Br J Surg. 2008 Jan;95(1):33-49. doi: 10.1002/bjs.6061.
- Background: PubMed 11547717Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.
- Background: PubMed 20096534Kusters M, Marijnen CA, van de Velde CJ, Rutten HJ, Lahaye MJ, Kim JH, Beets-Tan RG, Beets GL. Patterns of local recurrence in rectal cancer; a study of the Dutch TME trial. Eur J Surg Oncol. 2010 May;36(5):470-6. doi: 10.1016/j.ejso.2009.11.011. Epub 2010 Jan 21.
- Background: PubMed 11584199Nagawa 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(9):1274-80. doi: 10.1007/BF02234784.
- Background: PubMed 17197969Ueno H, Mochizuki H, Hashiguchi Y, Ishiguro M, Miyoshi M, Kajiwara Y, Sato T, Shimazaki H, Hase K. Potential prognostic benefit of lateral pelvic node dissection for rectal cancer located below the peritoneal reflection. Ann Surg. 2007 Jan;245(1):80-7. doi: 10.1097/01.sla.0000225359.72553.8c.
- Background: PubMed 12110792Watanabe T, Tsurita G, Muto T, Sawada T, Sunouchi K, Higuchi Y, Komuro Y, Kanazawa T, Iijima T, Miyaki M, Nagawa H. Extended lymphadenectomy and preoperative radiotherapy for lower rectal cancers. Surgery. 2002 Jul;132(1):27-33. doi: 10.1067/msy.2002.125357.
- Background: PubMed 17436337Yano H, Saito Y, Takeshita E, Miyake O, Ishizuka N. Prediction of lateral pelvic node involvement in low rectal cancer by conventional computed tomography. Br J Surg. 2007 Aug;94(8):1014-9. doi: 10.1002/bjs.5665.
- Background: PubMed 19767239Georgiou P, Tan E, Gouvas N, Antoniou A, Brown G, Nicholls RJ, Tekkis P. Extended lymphadenectomy versus conventional surgery for rectal cancer: a meta-analysis. Lancet Oncol. 2009 Nov;10(11):1053-62. doi: 10.1016/S1470-2045(09)70224-4. Epub 2009 Sep 18.
- Background: PubMed 17968166Kim JC, Takahashi K, Yu CS, Kim HC, Kim TW, Ryu MH, Kim JH, Mori T. Comparative outcome between chemoradiotherapy and lateral pelvic lymph node dissection following total mesorectal excision in rectal cancer. Ann Surg. 2007 Nov;246(5):754-62. doi: 10.1097/SLA.0b013e318070d587.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziqiang Wang, MD,PhD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLND and labeled line in people with Rectal Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The enrollment was too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year local recurrence (time frame: until local-recurrence (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02614157, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021; AzTrials last refreshed its copy on 28 Oct 2026.