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

NCT ID: NCT04296240

Last Updated: 2020-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2024-04-30

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant chemotherapy

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;

Group Type: EXPERIMENTAL

Oxaliplatin and capecitabine

Intervention Type: DRUG

Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months

Total Mesorectal Excision

Intervention Type: PROCEDURE

Patient receive total mesorectal excision after neoadjuvant chemotherapy

Interventions

Oxaliplatin and capecitabine

Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months

Intervention Type: DRUG

Total Mesorectal Excision

Patient receive total mesorectal excision after neoadjuvant chemotherapy

Intervention Type: PROCEDURE

Other Intervention Names

antiemetics; TME

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Aiwen Wu

chief, Unit III & Ostomy Service, Gastrointestinal Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiwen Wu

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinyu Wang

Role: CONTACT

wxy_196@163.com

+8618511834100

Other Identifiers

PKUCH-R03

Identifier Type: -

Identifier Source: org_study_id