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Comparison of Standard and High Dose Irinotecan Based on UGT1A1 Genotype, 5-fluorouracil, and Leucovorin (FOLFIRI) for First-line Treatment of Locally Advanced Colon Cancer: a Prospective Phase II Clinical Study


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colonic Neoplasms

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Trial Information

Comparison of Standard and High Dose Irinotecan Based on UGT1A1 Genotype, 5-fluorouracil, and Leucovorin (FOLFIRI) for First-line Treatment of Locally Advanced Colon Cancer: a Prospective Phase II Clinical Study


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:

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

R0 resection rate

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Xishan Wang, doctor

Investigator Role:

Study Chair

Investigator Affiliation:

Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CCIHeilongjiang-001

NCT ID:

NCT01826396

Start Date:

April 2013

Completion Date:

December 2014

Related Keywords:

  • Colonic Neoplasms
  • Neoplasms
  • Colonic Neoplasms

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