Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

NCT05563922 | Recruiting Phase 2

• 1 other identifier: B2022-334R
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

early low rectal cancer;total neoadjuvant treatment;TEM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical complete response rate after neoadjuvant chemoradiotherapy

  18 weeks

• 3-year local recurrence rate

  3 years

• 3-year distant metastases rate

  3 years

• 3-year Disease-free survival（DFS）rates

  3 years

• 3-year overall survival（OS） rates

  3 years

Study Arms (1)

Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEM

EXPERIMENTAL

All the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy （CapOx） until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated.

Combination Product: Total Neoadjuvant Chemoradiotherapy

Interventions

Total Neoadjuvant Chemoradiotherapy COMBINATION_PRODUCT

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

Also known as: Total Neoadjuvant Treatment

Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jian Wang, M.D.

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wang, M.D.

CONTACT

+8613816101686; wang.jian3@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the patients will receive neoadjuvant chemoradiotherapy ( CapOx + radiotherapy) for 2 cycles, one week after chemoradiotherapy, the first evaluation including MRI, colonoscopy, digital rectal examination and serum CEA will be conducted. Patients without tumor progression will continue 4 cycles of chemotherapy （CapOx） until next imaging and serum assessment. After the second assessment, for patients with tumor regression and suitable for TEM will receive local resection otherwise TME. Following treatment strategy will be made base on the final pathology evaluation after surgery, patients with good pathological response (ypT 0-1 without neural vascular invasion) will enter into the follow-up period, otherwise TME will be operated.

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: October 3, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)