UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
ConditionRectal Cancer Stage III
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Neoadjuvant chemoradiotherapy based on irinotecan
DrugPatients 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）.
Treatment groups
606 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant chemoradiotherapy based on irinotecanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete remission rate
The tumor disappeared completely and the tumor markers remained normal for at least 4 weeks.
Time frame
3 months after neoadjuvant chemoradiotherapy2
Locally recurrence rate
The proportion of recurrent rectal tumors in the total population after the complete regression of rectal tumors
Time frame
Within 5 years after the end of treatment3
DFS
The time from complete regression of the tumor after neoadjuvant therapy or radical resection to the first recurrence or death
Time frame
Within 5 years after the end of treatment4
OS
The time from enrolled in the study to death caused by any cause
Time frame
Within 5 years after the end of treatmentSponsors and contacts
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Source ClinicalTrials.gov