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Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma (OP-TNT)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Total Neoadjuvant Chemoradiotherapy
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring early low rectal cancer;total neoadjuvant treatment;TEM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEM

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
3-year local recurrence rate
Occurrence of local recurrence in patients with an organ preservation strategy
3-year distant metastases rate
Occurrence of distant metastases in patients with an organ preservation strategy
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-year overall survival（OS） rates
OS is defined as the time from enrollment to death due to any cause
Quality of life (EORTC-QLQ-C 30, psychological status)
Assess QLQ-C30 in patients with an organ preservation strategy
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-year overall survival（OS） rates
OS is defined as the time from enrollment to death due to any cause

Full Information

First Posted
September 4, 2022
Last Updated
September 28, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05563922
Brief Title
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Acronym
OP-TNT
Official Title
Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
early low rectal cancer;total neoadjuvant treatment;TEM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant concurrent Chemoradiotherapy plus consolidation chemotherapy followed by TEM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Total Neoadjuvant Chemoradiotherapy
Other Intervention Name(s)
Total Neoadjuvant Treatment
Intervention Description
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 Measure Information:
Title
Organ preservation rate at 3 years
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Clinical complete response rate after neoadjuvant chemoradiotherapy
Description
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
Time Frame
18 weeks
Title
3-year local recurrence rate
Description
Occurrence of local recurrence in patients with an organ preservation strategy
Time Frame
3 years
Title
3-year distant metastases rate
Description
Occurrence of distant metastases in patients with an organ preservation strategy
Time Frame
3 years
Title
3-year Disease-free survival（DFS）rates
Description
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
Time Frame
3 years
Title
3-year overall survival（OS） rates
Description
OS is defined as the time from enrollment to death due to any cause
Time Frame
3 years
Title
Quality of life (EORTC-QLQ-C 30, psychological status)
Description
Assess QLQ-C30 in patients with an organ preservation strategy
Time Frame
20 weeks
Title
5-year Disease-free survival（DFS）rates
Description
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
Time Frame
5 years
Title
5-year overall survival（OS） rates
Description
OS is defined as the time from enrollment to death due to any cause
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Wang, M.D.
Phone
+8613816101686
Email
wang.jian3@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Wang, M.D.
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Wang
Phone
+8613816101686
Email
wang.jian3@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

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