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Compares treatment options for Rectal Cancer
Official title The Efficacy of Primary Total Mesorectal Excision (TME) Surgery Versus Neoadjuvant Chemotherapy Combined With TME Surgery in Low-risk Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05984485
What this study is testing
- What it's testing
- 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 subsequently comparing the clinical outcomes of the two groups
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Newly diagnosed patients, aged 18 to 75 years;
- Pathologically confirmed rectal adenocarcinoma;
- Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
- High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative...
- Exclusion of patients with non-local recurrence or distant metastases;
You likely can't join if
- Patients with concurrent other malignancies or a history of malignant tumors in the past;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
- Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ...
- Patients with poor anal function or fecal incontinence before surgery;
- Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
- Patients recently diagnosed with other malignancies;
See the full eligibility criteria
- Newly diagnosed patients, aged 18 to 75 years;
- Pathologically confirmed rectal adenocarcinoma;
- Distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm;
- High-resolution MRI indicates low-risk locally advanced rectal cancer: T1-3bN1-2 or T3aN0 or T3bN0; no involvement of the anal sphincter; negative mesorectal fascia (MRF) status; negative extramural vascular invasion...
- Exclusion of patients with non-local recurrence or distant metastases;
- Absence of synchronous colorectal multiple primary cancers;
- Adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions;
- The study physician assessed no difficulty in sphincter preservation;
- patients and their families will be willing to participate in this study and provide written informed consent.
- Patients with concurrent other malignancies or a history of malignant tumors in the past;
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery;
- Patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection;
- Patients with poor anal function or fecal incontinence before surgery;
- Patients with a history of inflammatory bowel disease or familial adenomatous polyposis;
- Patients recently diagnosed with other malignancies;
- Patients with ASA grade ≥ IV and/or ECOG performance status score \> 2;
- Patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery;
- Patients with a history of severe mental illness;
- Pregnant or lactating women;
- Patients with uncontrolled infections before surgery;
- Patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Hengyang, Hunan, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Nanchong, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Hengyang, Hunan, China; Shenyang, Liaoning, China; Xi'an, Shaanxi, China; Nanchong, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.