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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

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

NCT ID

NCT04296240

First Posted

August 26, 2019

Last Updated

March 3, 2020

Sponsor

Peking University Cancer Hospital & Institute

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Learn more about this trial

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

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