NCT03587480Recruiting
Total Mesorectal Excision(TME) With Lateral Lymph Node Dissection Versus TME After Neoadjuvant Chemo-radiotherapy
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
Source: ClinicalTrials.gov · Last updated 25 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 28 Jun 2018
- Start date
- 17 Dec 2018
- Primary completion date
- 24 May 2025
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT03587480
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 17 Dec 2018 to the primary completion date, 24 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Past history of other cancers
- Multiple Primary Colorectal Cancers or Familial adenomatous polyposis(FAP)
- Combine with inflammatory bowl disease(IBD)
- Combine with obstruction,perforation or bleeding which need emergency surgery.
- Severity infection before operation
- Psychological disorder
- Cardiac infarction within six months
Other
- Recurrence tumor or invade other organs
- Local tumor invade the external sphincter, levator ani muscle or adjacent organs
- Participant join other clinical trials in 4 weeks.
- American Society of Anesthesiologists(ASA) ≥Ⅳ and/or Eastern Cooperative Oncology Group(ECOG) ≤2
- Pregnant or lactating patients
- Severe dysfunction of organs or other contraindications
- Severe pulmonary emphysema and pulmonary fibrosis
- Doctor's decision for exclusion
- Operative findings:
- Tumor invade other organs Lower tumor margin is above the peritoneal reflection
Who the study is looking for
- Histologically confirmed adenocarcinoma(below the peritoneal reflection) Clinical stage Ⅲ
- Tumor is capable of performing radical recession
- No past history of chemotherapy, pelvic radiation of other cancers.
- Written informed consent
- Lower tumor margin is confirmed below the peritoneal reflection
- 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 -
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliate Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.