The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
Recruiting
Phase 3
Interventional Study
Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 766 (estimated)
- Sponsor
- Sun Yat-sen University · Other
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About This Trial
Comparative analysis of the clinical efficacy between primary Total Mesorectal Excision (TME) surgery and neoadjuvant chemotherapy combined with TME surgery for low-risk locally advanced rectal cancer. Randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with TME surgery or the experimental group receiving primary TME surgery, and subsequen…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Newly diagnosed patients, aged 18 to 75 years;
2. Pathologically confirmed rectal adenocarcinoma;
3. Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
4. High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3a…
Contacts