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

NCT04296240 | Unknown Phase 2

• 1 other identifier: PKUCH-R03
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; neoadjuvant; chemotherapy

Outcome Measures

Primary Outcomes (1)

• pathologic complete response rate

  the number of patients with pCR divided by the total number of patients

  30 days

Secondary Outcomes (3)

• 3 year disease-free survival

  three years after the enrollment

• surgical complication rate

  30 days after the operation

• Toxicity of neoadjuvant chemotherapy

  4 months

Study Arms (1)

Neoadjuvant chemotherapy

EXPERIMENTAL

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;

Drug: Oxaliplatin and capecitabine; Procedure: Total Mesorectal Excision

Interventions

Oxaliplatin and capecitabine DRUG

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

Also known as: antiemetics

Neoadjuvant chemotherapy

Total Mesorectal Excision PROCEDURE

Patient receive total mesorectal excision after neoadjuvant chemotherapy

Also known as: TME

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Oxaliplatin; Capecitabine; Antiemetics

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Officials

• Aiwen Wu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyu Wang

CONTACT

+8618511834100; wxy_196@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief, Unit III & Ostomy Service, Gastrointestinal Cancer

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: March 5, 2020
• Study Start: March 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2024
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)