Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers think that some people whose initially locally advanced colorectal cancer has no remaining cancer in nearby lymph nodes after preoperative chemotherapy or chemoradiotherapy may not need more chemotherapy after surgery. The trial is testing watchful follow-up against adjuvant chemotherapy, which is treatment given after surgery, in people whose surgical stage is pT0–3N0M0.
The comparison asks whether avoiding postoperative chemotherapy can preserve disease-free survival while sparing people its side effects. The main measure is how long people remain free of cancer or recurrence, not overall survival.
Worth knowing: This is a randomised trial, but its result will mainly address disease-free survival and only the relatively narrow group whose cancer is down-staged to pT0–3N0M0 after preoperative treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT03748485 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 650 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sixth Affiliated Hospital, Sun Yat-sen University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Behavioural wait and watch
- Drug adjuvant chemotherapy
What it is measuring
disease free survival
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- 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
Exclusion Criteria
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses).
- Colorectal tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
- 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.
- Not controlled pre-operational infection.
- Enrolled in other clinical trials within 4 weeks.
- Other clinical or laboratorial condition not recommended by investigators.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT03748485, registered by Sixth Affiliated Hospital, Sun Yat-sen University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.