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Recruiting NCT05563922

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

Phase II Interventional Rectal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Neoadjuvant Chemoradiotherapy.
Who it may be relevant to
Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial

Overview

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.

Interventions

  • Combination product Total Neoadjuvant Chemoradiotherapy
    Radiotherapy：45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week CapOx: Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection

Primary outcome measures

  • Organ preservation rate at 3 years [Time frame: 3 years]
Secondary outcome measures (8)
  • Clinical complete response rate after neoadjuvant chemoradiotherapy [Time frame: 18 weeks]
  • 3-year local recurrence rate [Time frame: 3 years]
  • 3-year distant metastases rate [Time frame: 3 years]
  • 3-year Disease-free survival（DFS）rates [Time frame: 3 years]
  • 3-year overall survival（OS） rates [Time frame: 3 years]
  • Quality of life (EORTC-QLQ-C 30, psychological status) [Time frame: 20 weeks]
  • 5-year Disease-free survival（DFS）rates [Time frame: 5 years]
  • 5-year overall survival（OS） rates [Time frame: 5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT05563922 · B2022-334R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗