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Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CapeOX + cetuximab
CapeOX + bevacizumab
radiotherapy
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 18 and 70; Histologically confirmed adenocarcinoma of rectum; The distance from the lower edge of the tumor to the anus is ≤ 10cm; ECOG score ≤ 1; Have not received any anti-tumor treatment before; Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis) Hematological indicators and liver and kidney function within 7 days are within the normal range; Sign the informed consent form and be able to follow the research and /or follow-up procedures. Exclusion Criteria: Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer; The patient had a history of malignant tumor within 5 years; Pregnant or lactating women; The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery; The patient has had radiotherapy and chemotherapy records before this visit; Distant metastasis was found during operation; Patients with poor radiotherapy compliance and difficult cooperation;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    radiotherapy removal TNT plus group

    Arm Description

    Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant patients, and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.

    Outcomes

    Primary Outcome Measures

    tumor regression grading, TRG
    Reference resist 1.1 rating

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2022
    Last Updated
    September 12, 2023
    Sponsor
    Tang-Du Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06035133
    Brief Title
    Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy
    Official Title
    One Arm Exploratory Trial of Efficacy and Safety of TNT Plus Mode With Neoadjuvant Radiotherapy in the Treatment of Locally Advanced Medium-low Rectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 10, 2023 (Anticipated)
    Primary Completion Date
    November 10, 2024 (Anticipated)
    Study Completion Date
    November 10, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tang-Du Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    (1) To evaluate the oncological effects of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode on TRG, Anal sphincter preservation surgery rate / rectal preservation surgery rate, cCR rate, pCR rate and other oncological effects in patients with middle and low LARC; (2) Evaluate the R0 resection rate, LARS score, urination function and sexual function score, local recurrence rate, and 3-year DFS and OS of Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT plus mode, resolve the current dispute about the Treatment of low locally advanced rectal cancer with radiotherapy removal TNT plus neoadjuvant therapy TNT treatment mode of LARC, provide a new mode for LARC treatment, and hopefully rewrite the diagnosis and treatment guidelines for rectal cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    213 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    radiotherapy removal TNT plus group
    Arm Type
    Experimental
    Arm Description
    Six induction chemotherapy rounds of the CapeOX regimen were administered. RAS, BRAF, and MSI were found when the first patients were examined. Patients were given CapeOX + cetuximab for RAS wild-type patients, CapeOX + bevacizumab for RAS mutant patients, and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks. A surgical procedure was carried out two weeks after consolidation chemotherapy ended.
    Intervention Type
    Drug
    Intervention Name(s)
    CapeOX + cetuximab
    Intervention Description
    CapeOX + cetuximab for RAS wild-type patients and CapeOX + cetuximab for MSI-H patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    CapeOX + bevacizumab
    Intervention Description
    CapeOX + bevacizumab for RAS mutant patients. The CapeOX regimen: Oxaliplatin 130 mg/m2, intravenous injection, day 1; capecitabine 1000 mg/m2, oral, twice daily, days 1 through 14; once every 3 weeks.
    Intervention Type
    Radiation
    Intervention Name(s)
    radiotherapy
    Intervention Description
    radiotherapy
    Primary Outcome Measure Information:
    Title
    tumor regression grading, TRG
    Description
    Reference resist 1.1 rating
    Time Frame
    one month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 70; Histologically confirmed adenocarcinoma of rectum; The distance from the lower edge of the tumor to the anus is ≤ 10cm; ECOG score ≤ 1; Have not received any anti-tumor treatment before; Preoperative abdominal enhanced CT or MRI showed cT4, cN0-2; M0 chest and abdomen CT showed no obvious metastasis. (Note: PET-CT is recommended when small nodules can not be identified by liver or lung CT, and can still be included in the group when considering the possibility of metastasis) Hematological indicators and liver and kidney function within 7 days are within the normal range; Sign the informed consent form and be able to follow the research and /or follow-up procedures. Exclusion Criteria: Have serious basic diseases, such as heart disease, renal failure, severe liver failure or liver failure, coagulation dysfunction, etc; Postoperative recurrence of colorectal cancer; The patient had a history of malignant tumor within 5 years; Pregnant or lactating women; The patient has a history of adjuvant radiotherapy for other system diseases, and surgical contraindications, so it is not suitable for surgery; The patient has had radiotherapy and chemotherapy records before this visit; Distant metastasis was found during operation; Patients with poor radiotherapy compliance and difficult cooperation;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nan Wang, Dr
    Phone
    15719286297
    Email
    wangnandoc@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Low Locally Advanced Rectal Cancer With Radiotherapy Removal TNT Plus Neoadjuvant Therapy

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