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Compares treatment options for Chemotherapy Effect
Official title Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
ClinicalTrials.gov ID: NCT06043999
What this study is testing
- What it's testing
- Whether to perform radical TME or salvage chemoradiotherapy after local resection of intermediate-risk T1 rectal cancer is still controversial. A study based on the National Cancer Data Center showed that, because of the need for organ preservation, rescue chemoradiotherapy after local resection of rectal cancer was used in 10% of patients with T1N0 tumors and in 40% of patients with T2N0 tumors.
- Which group you join is decided by chance.
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
- aged 18-75 years;
- Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy)
- pT1 with a diameter of 3-5 cm, or a maximum diameter of 3 cm, and at least poor differentiation and/or lymphovascular invasion and/or perineural...
- The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis;
- clinical stage N0M0 at initial diagnosis;
You likely can't join if
- complicated with other malignant tumors or a previous history of malignant tumors;
- not suitable for subsequent chemoradiotherapy or surgery;
- a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
- recently diagnosed with other malignant tumors;
- ASA physical status ≥ IV and/or ECOG performance status \> 2 points;
- patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can...
See the full eligibility criteria
- aged 18-75 years;
- Local radical resection of rectal adenocarcinoma (TEM, TAMIS, TSPM, EMR, ESD or polypectomy)
- pT1 with a diameter of 3-5 cm, or a maximum diameter of 3 cm, and at least poor differentiation and/or lymphovascular invasion and/or perineural invasion and/or SM3;
- The distance from the lower edge of the tumor to the anal verge was within 10cm on MRI at initial diagnosis;
- clinical stage N0M0 at initial diagnosis;
- no multiple colorectal cancer;
- The heart, lung, liver and kidney function can tolerate surgery;
- Patients and their families were able to understand and willing to participate in this study, and provided written informed consent
- complicated with other malignant tumors or a previous history of malignant tumors;
- not suitable for subsequent chemoradiotherapy or surgery;
- a history of inflammatory bowl disease (IBD) or familial adenomatous polyposis (FAP);
- recently diagnosed with other malignant tumors;
- ASA physical status ≥ IV and/or ECOG performance status \> 2 points;
- patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases can not tolerate surgery;
- a history of severe mental illness;
- pregnant or lactating women;
- Patients with other clinical or laboratory conditions were not considered to be eligible for the study
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.