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Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin and capecitabine
Total Mesorectal Excision
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, neoadjuvant, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Age ≥18 years and ≤80 years

    • ECOG Performance status 0-1
    • Histologically confirmed diagnosis of adenocarcinoma of the rectum
    • The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy;
    • Clinical Stage based on MRI

      1. mrMRF(-)
      2. T3c/T3d/T4a, anyN, or T3bN+
    • No evidence of distant metastases
    • No prior pelvic radiation therapy
    • No prior chemotherapy or surgery for rectal cancer
    • No active infections requiring systemic antibiotic treatment
    • ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN.
    • Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion Criteria:

  • • Recurrent rectal cancer

    • Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins.
    • The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer.
    • Creatinine level greater than 1.5 times the upper limit of normal.
    • Patients who have received prior pelvic radiotherapy.
    • Patients who are unable to undergo an MRI.
    • Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
    • Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.
    • Other Anticancer or Experimental Therapy.
    • Women who are pregnant or breast-feeding.
    • Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

Sites / Locations

  • Beijing Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant chemotherapy

Arm Description

Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;

Outcomes

Primary Outcome Measures

pathologic complete response rate
the number of patients with pCR divided by the total number of patients

Secondary Outcome Measures

3 year disease-free survival
cumulative rate of survival without cancer after 3 years follow up
surgical complication rate
rate of patients who had surgical complications during the perioperative period
Toxicity of neoadjuvant chemotherapy
category and grade of adverse event during neoadjuvant chemotherapy

Full Information

First Posted
August 26, 2019
Last Updated
March 3, 2020
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04296240
Brief Title
Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer
Official Title
Safety and Efficacy of Induction and Individualized Neoadjuvant Chemotherapy Based on Oxaliplatin Combined With Fluorouracil for MRF-negative, Moderate-risk and Initially Resectable Middle and Low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

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

5. Study Description

Brief Summary
This study is designed to test the Safety and efficacy of induction and individualized neoadjuvant chemotherapy based on oxaliplatin combined with fluorouracil for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer.
Detailed Description
Preoperative chemoradiation has become standard treatment for stage 2/3 rectal cancer. But for moderate-risk rectal cancer patients, whether neoadjuvant chemotherapy followed with total mesorectal excision is adequate for local control is still unknown. The necessity of preoperative radiotherapy for these patients needs further exploration. This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of neoadjuvant chemotherapy for MRF-negative, moderate-risk and initially resectable middle and low rectal cancer. In this study, patients with MRI defined moderate-risk rectal cancer will receive a three-month neoadjuvant chemotherapy based on Oxaliplatin combined with Fluorouracil(CapeOX,SOX,mFOLFOX6,etc.) and Total mesorectal excision. Primary Endpoint is pCR rate.Secondary endpoint concludes toxic reactions of neoadjuvant chemotherapy, Incidence of surgical complications and three-year disease-free survival (DFS). This study is designed to recruit 119 patients in all.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
Oxaliplatin 130mg/m2 d1 and Capecitabine 1250mg/m2 bid1-14 or other fluorouracils, every 21 or 14 days for 2 to 4 cycles, and efficacy evaluation every 2 cycles;
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin and capecitabine
Other Intervention Name(s)
antiemetics
Intervention Description
Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months
Intervention Type
Procedure
Intervention Name(s)
Total Mesorectal Excision
Other Intervention Name(s)
TME
Intervention Description
Patient receive total mesorectal excision after neoadjuvant chemotherapy
Primary Outcome Measure Information:
Title
pathologic complete response rate
Description
the number of patients with pCR divided by the total number of patients
Time Frame
30 days
Secondary Outcome Measure Information:
Title
3 year disease-free survival
Description
cumulative rate of survival without cancer after 3 years follow up
Time Frame
three years after the enrollment
Title
surgical complication rate
Description
rate of patients who had surgical complications during the perioperative period
Time Frame
30 days after the operation
Title
Toxicity of neoadjuvant chemotherapy
Description
category and grade of adverse event during neoadjuvant chemotherapy
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Age ≥18 years and ≤80 years ECOG Performance status 0-1 Histologically confirmed diagnosis of adenocarcinoma of the rectum The distance from down verge of tumor to anal-rectal junction (ARJ) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy; Clinical Stage based on MRI mrMRF(-) T3c/T3d/T4a, anyN, or T3bN+ No evidence of distant metastases No prior pelvic radiation therapy No prior chemotherapy or surgery for rectal cancer No active infections requiring systemic antibiotic treatment ANC > 1.5 cells/mm3, HGB > 10.0 g/dL, PLT > 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 3 x ULN. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Exclusion Criteria: • Recurrent rectal cancer Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins. The pathological grade was Grade 4, i.e. mucus, signet ring or undifferentiated cancer. Creatinine level greater than 1.5 times the upper limit of normal. Patients who have received prior pelvic radiotherapy. Patients who are unable to undergo an MRI. Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer. Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA. Other Anticancer or Experimental Therapy. Women who are pregnant or breast-feeding. Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinyu Wang
Phone
+8618511834100
Email
wxy_196@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiwen Wu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Induction Chemotherapy for MRF-negative, Moderate-risk, Resectable Middle and Low Rectal Cancer

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