Recruiting nowPhase 3Randomised
| Registry number | NCT04215731 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 582 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | Yanhong Deng |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab
- Procedure Restaging
- Radiotherapy Concomitant Chemoradiotherapy
- Procedure Surgery
- Radiotherapy Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)
- Drug Induction chemotherpay with FOLFOX
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.
What this trial is trying to do
The researchers are testing intensive chemotherapy with mFOLFOXIRI plus bevacizumab before surgery, with chemoradiotherapy added only if restaging shows features such as an involved mesorectal fascia or locally advanced disease. The idea is to treat possible microscopic spread early and spare some patients the long-term effects of pelvic radiation without losing local tumour control.
Compared with standard treatment that routinely includes preoperative chemoradiotherapy, this approach is intended to reduce distant relapses while limiting radiation-related bowel, urinary and sexual problems. The main test is whether it improves disease-free survival, meaning the time before the cancer returns or progresses.
Worth knowing: Disease-free survival is the main outcome rather than overall survival, and the treatment is aimed at a relatively narrow group with high-risk locally advanced rectal cancer.
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.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
Multimodality treatment that comprises preoperative fluoropyrimidine with concurrent radiotherapy followed by total mesorectal excision (TME) surgery and adjuvant fluoropyrimidine-based chemotherapy is recommended as a standard treatment of patients with stage II/III rectal cancer. However, the main target of radiotherapy is local control but no improvement in disease-free survival (DFS) or overall survival (OS) has been shown with this treatment strategy, which leaves approximately 30% of patients in whom distant metastases will develop. Moreover, the short- and long-term adverse effects of radiotherapy such as chronic pain, faecal incontinence and urogenital/anal dysfunction are associated with poor quality of life.
Neadajuvant chemotherpay (NACT) alone has been proposed instead of preoperative chemoradiotherapy (CRT) with the aim of elimination of potential micrometastasis as early as possible while avoiding the adverse effects of radiotherapy, without jeopardizing local control.
Evidence from the UK CR07 trial suggests that, without RT, a local recurrence rate of 5% (27/543) can be achieved if a complete mesorectal excision is carried out with a negative CRM.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- Rectal
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
1. Willing and able to provide written informed consent.
2. Male or female subjects > 18 years < 70 of age.
3. Histological or cytological documentation of adenocarcinoma of the rectal (<12 cm from the anal verge).
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Evaluated by pelvic contrast-enhanced MRI as having high-risk locally advanced disease: cT3 with mesorectal fascia involvement, or cT4a/b, or positive lateral lymph nodes (TNM staging reference provided).
6. No prior systemic anti-cancer therapy for colorectal cancer, including cytotoxic drugs, immune checkpoint inhibitors, molecular targeted therapy, or endocrine therapy.
7. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment
8. Willing and able to comply with the study protocol and visit schedule.
Exclusion Criteria
1. Evidence of distant metastasis (M1) confirmed by systemic CT, MRI, or PET-CT (at minimum including chest, abdomen, and pelvis).
2. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
3. Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery.
4.
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 NCT04215731, registered by Yanhong Deng 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.