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New treatment option for Rectal Cancer
Official title Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
ClinicalTrials.gov ID: NCT05563922
What this study is testing
What is Total Neoadjuvant Chemoradiotherapy?
Total Neoadjuvant Chemoradiotherapy is an investigational medicine, being studied as a potential treatment for rectal cancer.
Also referred to as Total Neoadjuvant Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery （TEM） or endoscopic local resection for early low rectal cancer（cT 1-3N0M0）.Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life （QoL） will also be assessed.
- Phase 2: a mid-size study of how well it works
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
- Age≥18 years
- cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy
- Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge
- Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment, meanwhile is suitable for the implementation...
- No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
You likely can't join if
- Have received previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
- Patients with concurrent colorectal organic diseases
- Patients with familial polyposis
- Patients with a previous history of colorectal surgery or pelvic radiotherapy that may affect the outcome of this treatment
- Pregnant or lactating women
- The patient or family members could not understand the conditions and objectives of this study
See the full eligibility criteria
- Age≥18 years
- cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy
- Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge
- Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment, meanwhile is suitable for the implementation of organ preservation strategy after discussion within the...
- No previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
- No contraindications to chemoradiotherapy
- No other colorectal organic diseases
- Voluntarily sign the informed consent
- Have received previous treatment (including endoscopic resection, transanal local resection, radiotherapy, chemotherapy, etc.) before enrollment
- Patients with concurrent colorectal organic diseases
- Patients with familial polyposis
- Patients with a previous history of colorectal surgery or pelvic radiotherapy that may affect the outcome of this treatment
- Pregnant or lactating women
- The patient or family members could not understand the conditions and objectives of this study
- With a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, their clinical severity may hinder the signing of an informed consent form or affect their compliance with oral medication
- It is difficult to achieve complete remission base on existing evidence , such as: maximum diameter of cT2/T3 tumor\>4cm; suspicious Lateral lymph nodes (maximum diameter) =5mm; baseline CEA≥100; biopsy pathology...
- Organ transplantation requires immunosuppressive therapy
- Serious uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- The baseline blood routine and biochemical indexes of the subject do not meet the following criteria: hemoglobin ≥90g / L; absolute neutrophil count (ANC) ≥1.5\ 10\^9 / L; platelet ≥100\ 10\^9 / L; ALT and AST≤ 2.5...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, 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.