NCT05148767RecruitingPhase 4
UGT1A1-Based Irinotecan Therapy for Locally Advanced Rectal Cancer
Neoadjuvant Chemoradiation With Irinotecan Guided by UGT1A1 Status in Patients With Locally Advanced Rectal Cancer: A Real-Word Multi-center Study
Source: ClinicalTrials.gov · Last updated 8 Dec 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 606 (estimated)
- First submitted
- 7 Oct 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Zhejiang Cancer Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT05148767
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 606
- From 1 Jan 2022 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
Other illness
- 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
- Anyone who is allergic to any research medication
Lab values
- 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
Other
- Pregnant or breastfeeding women
- DPD deficiency
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.