UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer

NCT05148767 | Recruiting Phase 4 DMC

• 1 other identifier: CARTOnG-2003
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

Brief Summary

To explore whether the application of irinotecan under the guidance of UGT1A1 gene in neoadjuvant chemotherapy and radiotherapy for locally advanced rectal cancer could improve the clinical efficacy in the real world.

Conditions

Rectal Cancer Stage III

Keywords

locally advanced rectal cancer; Neoadjuvant chemoradiotherapy; irinotecan

Outcome Measures

Primary Outcomes (5)

• Complete remission rate

  The tumor disappeared completely and the tumor markers remained normal for at least 4 weeks.

  3 months after neoadjuvant chemoradiotherapy

• Locally recurrence rate

  The proportion of recurrent rectal tumors in the total population after the complete regression of rectal tumors

  Within 5 years after the end of treatment

• DFS

  The time from complete regression of the tumor after neoadjuvant therapy or radical resection to the first recurrence or death

  Within 5 years after the end of treatment

• OS

  The time from enrolled in the study to death caused by any cause

  Within 5 years after the end of treatment

• Toxicity effect

  Any adverse reactions caused by neoadjuvant chemoradiotherapy or surgery

  Within 5 years after the end of treatment

Study Arms (1)

Neoadjuvant chemoradiotherapy based on irinotecan

EXPERIMENTAL

Locally advanced rectal cancer patients who were treated with irinotecan-based neoadjuvant chemoradiotherapy regimen can be enrolled in this group.

Drug: Neoadjuvant chemoradiotherapy based on irinotecan

Interventions

Neoadjuvant chemoradiotherapy based on irinotecan DRUG

Patients with locally advanced rectal cancer treated with irinotecan-based chemoradiotherapy were enrolled in this study. The dose of irinotecan is determined by the genotype of UGT1A1.Concurrent Chemoradiotherapy: Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2 (UGT1A1\*28 and \*6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1\*28 and \*6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Neoadjuvant chemoradiotherapy based on irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed rectal adenocarcinoma
• Clinical stage T3-4 and / or Nude positive, and the treatment plan is nCRT.
• Without distance metastases
• A need for tumor withdrawal.
• Aged 18-75 years old, regardless of gender.
• ECOG score 0-2.
• Detection of UGT1A1\*6 and \* 28 gene status.
• Be able to comply with the plan during the study period.
• Sign the inform consent

You may not qualify if:

• Pregnant or breastfeeding women
• Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
• If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
• Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
• Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
• Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L
• Anyone who is allergic to any research medication
• DPD deficiency

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Officials

• Ji Zhu, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Zhu, MD

CONTACT

571-88128142; leo.zhu@126.com

Quanquan Sun, MD

CONTACT

571-88128142; sunqq@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: December 8, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

CN (1)