Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

Rectal Cancer Clinical Trial

— OP-TNT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563922
• Other study ID #: B2022-334R
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: September 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Jian Wang, M.D.
• Phone: +8613816101686
• Email: wang.jian3[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Fudan University Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ preservation rate at 3 years	Patients with a good pathological response(ypT 0-1 without neural vascular invasion)after neoadjuvant treatment followed by transanal endoscopic microsurgery(TEM)or endoscopic local resection will be offered an organ preservation strategy	3 years
Secondary	Clinical complete response rate after neoadjuvant chemoradiotherapy	Define as complete withdrawal of rectal cancer after neoadjuvant radiotherapy and chemotherapy, and no distant metastasis in imaging examination, and no tumor residue in imaging examination and endoscopic biopsy	18 weeks
Secondary	3-year local recurrence rate	Occurrence of local recurrence in patients with an organ preservation strategy	3 years
Secondary	3-year distant metastases rate	Occurrence of distant metastases in patients with an organ preservation strategy	3 years
Secondary	3-year Disease-free survival(DFS)rates	Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause	3 years
Secondary	3-year overall survival(OS) rates	OS is defined as the time from enrollment to death due to any cause	3 years
Secondary	Quality of life (EORTC-QLQ-C 30, psychological status)	Assess QLQ-C30 in patients with an organ preservation strategy	20 weeks
Secondary	5-year Disease-free survival(DFS)rates	Disease free survival defined as the time from enrollment to the first documented disease progression of local recurrence or distance metastasis or death due to any cause	5 years
Secondary	5-year overall survival(OS) rates	OS is defined as the time from enrollment to death due to any cause	5 years