NCT03748485Recruiting
Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
Comparing the Treatment Efficacy in Clinical Local Advanced Colorectal Cancer (cTxN1/2M0) Following Preoperational Adjuvant Therapies and Pathologically Proved StageⅡ(pT0-3N0M0)With or Without Adjuvant Chemotherapy
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
Adjuvant chemotherapy was unnecessary in pathological stage Ⅱ colorectal cancer following initial treatment of surgery without high risk factors of recurrences. The treatment efficacy of adjuvant chemotherapy for pT1-3N0M0 colorectal cancer following preoperational chemotherapy or chemoradiotherapy remains unclear. Part of clinical local advanced colorectal cancer(cTxN1-2M0), which turn out to be pT0-3N0M0 after preoperational chemotherapy or chemoradiotherapy, might not really need adjuvant chemotherapy due to the down-stage efficacy of the preoperational treatments, or the misleading by lymph nodes false-positive imaging diagnosis.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 650 (estimated)
- First submitted
- 15 Nov 2018
- Start date
- 30 Apr 2019
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT03748485
What you commit to
- Study type: Interventional
- Planned participants: 650
- From 30 Apr 2019 to the primary completion date, 30 Dec 2027
- 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.
Prior treatment
- Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
Other illness
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).
- Not controlled pre-operational infection.
- Other clinical or laboratorial condition not recommended by investigators.
Other
- Non resectable lymph node metastasis.
- American Society of Anesthesiologists (ASA) grading≥ IV and/or, Eastern Cooperative Oncology Group(ECOG) score≥ 2.
- Physical or psychological dependence.
- Pregnant or breast feeding women.
- Enrolled in other clinical trials within 4 weeks.
Who the study is looking for
- preoperative clinical tumor stage III （TxN1-2M0）CRC
- pathological proved CRC adenocarcinoma by endoscopic biopsy
- Post operational pathological T0-3N0M0 without high risk factors of recurrence
- Patient able to understand and sign written informed consent
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 |
|---|---|---|---|
| Sixth Affiliated 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.