Organ preservation approach for early low rectal cancer
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial
This study is testing a new treatment plan for early low rectal cancer that combines chemotherapy and radiation with less invasive surgery to see if it can help patients keep their organs and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05563922 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of an organ-sparing strategy involving total neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery or endoscopic local resection for patients with early low rectal cancer. It focuses on assessing clinical complete response rates, organ preservation rates, local recurrence rates, distant metastasis rates, and quality of life outcomes. The study aims to provide a less invasive treatment option while maintaining cancer control.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with early low rectal adenocarcinoma who wish to preserve their anus and are suitable for neoadjuvant treatment.
Not a fit: Patients who have received prior treatments for rectal cancer or have concurrent colorectal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow patients to preserve their anal function while effectively treating early low rectal cancer.
How similar studies have performed: Other studies have shown promising results with similar organ preservation strategies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 multidisciplinary team of the hospital * 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 Exclusion Criteria: * 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 contains signet ring cell carcinoma mucinous adenocarcinoma; evaluation team determines whether circumferential constrictive tumor should be included or not when necessary Severe heart disease, such as symptomatic coronary heart disease, New York Cardiology Association (NYHA) grade II or above severe congestive heart failure, or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months * 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 times normal upper limit; ALP ≤2.5 times normal upper limit; serum total bilirubin \<1.5 times normal upper limit; serum normal creatinine"\<1 time upper limit; and serum albumin ≥30g / L
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jian Wang, M.D. — Shanghai Zhongshan Hospital
- Study coordinator: Jian Wang, M.D.
- Email: wang.jian3@zs-hospital.sh.cn
- Phone: +8613816101686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.