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Status unknownNCT01826396Updated Apr 8, 2013

Standard and High Dose Irinotecan Based on UGT1A1 Genotype for First-line Treatment of Locally Advanced Colon Cancer

A Phase 2 interventional study of Irinotecan in Colonic Neoplasms, sponsored by Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-08.

Sponsored by Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

In the current treatment of colon cancer, the definition of locally advanced colon cancer (LACC) is controversial, and the clinical trial evidence which support treatment for LACC is not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also could be effectively applied for patients with locally advanced colon cancer? It is worthy of clinicians to conduct research. In recent studies, the literature indicated that the the uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous variant genotypes was significantly lower compared with the wild genotype. The studies based on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms has not yet come to the consistency of conclusions. The frequency of UGT1A1 gene polymorphisms between different races is significant different, irinotecan dose exploratory study based on Chinese patients has not been carried out.

This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of UGT1A1.

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Conditions studied

  • Colonic Neoplasms

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03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's planned enrollment of 100 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18 to 70 years old, male or female;
  2. ECOG performance status of 0-1;
  3. Confirm the diagnosis pathologically locally advanced colon adenocarcinoma;
  4. TNM stage is T4NxM0;
  5. According to RECIST 1.1 version of the standard, at least measurable lesions without local treatment; spiral CT or magnetic resonance imaging (MRI), thickness ≤ 5 mm lesion diameter ≥ 10mm, such as lymph short diameter required ≥ 15mm;
  6. Each organ function was normal (in the case of no ongoing support therapy, enrolled within one week of the laboratory examination results); 1)absolute neutrophil count (ANC) ≥ 1.5x109 / L, platelet count ≥ 80x109 / L, hemoglobin 9g/dL; 2)serum total bilirubin ≤ 1.5 times the upper limit of normal; 3)ALT and AST ≤ 2.5 times the upper limit of normal without liver metastases, liver metastases ≤ upper limit of normal in ALT and AST 5 times; 4)≤ upper limit of normal, serum creatinine or creatinine clearance ≥ 50ml/min.
  7. This study has been fully understood and voluntarily signed the informed consent form;
  8. Expected to survive for more than three months.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or lactating women or fertility patients are reluctant to take contraceptive measures;
  2. who are allergic to irinotecan, fluorouracil;
  3. can not be controlled in the central nervous system (CNS) metastasis;
  4. Suffering from any other malignancy (fully cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer excluded) within five years. 5.Clinical uncontrolled active infection such as acute pneumonia, with active hepatitis B;

6.with severe systemic disease, including, but not limited to, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, acute myocardial infarction, unstable angina, congestive heart failure, severe arrhythmia, thrombosis occurred within 6 months or embolic events (including transient ischemic attack); 7.Acute or subacute intestinal obstruction; 8.Symptoms of ascites, pleural effusion, and pericardial effusion, can not draining or symptomatic treatment control; 9.according to the NCI CTC AE 3.0 standard 2 or more than 2 toxicity or researchers believe that patients with any clinical or laboratory abnormalities are unfit to participate in the clinical research; 10.Also accept other systemic anti-cancer therapy (local radiotherapy of bone metastases from this restriction) to accept other trial medication in the 4 weeks before the start of the study; 11.History of serious psychological or psychiatric disorders, drug addiction or alcohol dependent persons; 12.estimated that the lack of compliance of patients enrolled in the clinical study.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    high dose irinotecan

    high dose irinotecan based on UGT1A1 genotype, 5-fluorouracil, and leucovorin (FOLFIRI) for first-line treatment of locally advanced colon cancer

    Drug: Irinotecan

Interventions

  • DrugIrinotecan

    Comparison of standard and high dose irinotecan

    Also known as: CPT-11, CAMPTO

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What researchers measure

Primary outcomes

  1. R0 resection rate

    Time frame: one year

Secondary outcomes

  1. disease free survival

    Time frame: one year

Other outcomes

  1. adverse reactions

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences
    Harbin, Heilongjiang 150001, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01826396
Lead sponsor
Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences
Responsible party
Sponsor
First posted
Apr 8, 2013
Start date
Apr 2013
Primary completion
Apr 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Apr 8, 2013

Study contacts

Zheng Jiang, doctor
Contact
dr.jiangzheng@gmail.com
+81 451 86297661
Xishan Wang, doctor
study chair · Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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