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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296240
• Other study ID #: PKUCH-R03
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2019
• Est. completion date: April 2024

Study information

• Verified date: March 2020
• Source: Beijing Cancer Hospital
• Contact: Xinyu Wang
• Phone: +8618511834100
• Email: wxy_196[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 119
• Est. completion date: April 2024
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin and capecitabine
Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months

Procedure:
• Total Mesorectal Excision
Patient receive total mesorectal excision after neoadjuvant chemotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response rate	the number of patients with pCR divided by the total number of patients	30 days
Secondary	3 year disease-free survival	cumulative rate of survival without cancer after 3 years follow up	three years after the enrollment
Secondary	surgical complication rate	rate of patients who had surgical complications during the perioperative period	30 days after the operation
Secondary	Toxicity of neoadjuvant chemotherapy	category and grade of adverse event during neoadjuvant chemotherapy	4 months