UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005011 |
|---|---|
| Receipt number | R000005962 |
| Scientific Title | Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer |
| Date of disclosure of the study information | 2011/02/03 |
| Last modified on | 2013/08/03 09:23:49 |
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Basic information
Public title
Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer
Acronym
Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for advanced Colorectal Cancer
Scientific Title
Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for Unresectable or Recurrent Colorectal Cancer
Scientific Title:Acronym
Genetic Polymorphism oriented Phase II Study of Irinotecan and Doxifluridine for advanced Colorectal Cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Primary endpoint: Response rate
Secondary endpoints: Overall survival, Progression-free survival, toxicity and safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28.
Interventions/Control_2
Irinotecan was infused 150 mg/m2 for pts with *1/*1 genotype and 70 mg/m2 for *1/*28.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were eligible for this study if they met the following criteria: proven unresectable or recurrent colorectal cancer; age between 20 and 80 years; no radiotherapy or chemotherapy prior to the study; Eastern Cooperative Oncology Group performance status of 0 to 1;predicted life expectancy of at least 3 months; adequate baseline organ functions, defined as a leukocyte count of at least 4,000/uL, neutrophil count of at least 2,000/uL, platelet count of at least 100,000/uL, hemoglobin of at least 9.0 g/dL, AST and ALT of 3 times or less the upper limit of the institutional reference range; total bilirubin below 1.5 mg/dL, and serum creatinine below 1.5 mg/dL.
Key exclusion criteria
Patients were ineligible if they had any of the following conditions: serious infectious disease or other severe complications (e.g., pulmonary fibrosis/interstitial pneumonia, uncontrollable diabetes); watery diarrhea, paralytic ileus, or intestinal obstruction; massive pleural effusion or ascitic fluid; symptomatic brain metastases; active concurrent malignancies; pregnancy or lactation, or desire for pregnancy; a history of drug allergy; and prior treatment with irinotecan.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Hazama |
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
Homepage URL
hazama@yamaguchi-u.ac.jp
Sponsor or person
Institute
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Institute
Department
Personal name
Funding Source
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ar.iiarjournals.org/content/33/8/3423.long
Number of participants that the trial has enrolled
Results
Abstract. Aim: We performed a phase II study of irinotecan
with 5-deoxy-5-fluorouridine (5-DFUR) for metastatic
colorectal cancer based on UDP-glucuronosyltransferase
(UGT) 1A1 polymorphism. Patients and Methods: A total of
28 patients were enrolled. The dose of irinotecan was
150 mg/m2 for patients with the *1/*1 wild-type genotype,
and 70 mg/m2 for those with the *1/*28 mutated genotype.
The primary end-point was the response rate (RR); secondary
end-points were safety, time to treatment failure (TTF), and
overall survival (OS). Results: In 28 patients total, genotype
was wild-type in 22 and mutated in six. The RR was *1/*1
(22.7%; wild-type) vs. *1/*28 (16.7%; mutated); the median
TTF was 5 months vs. 4.5 months, and the median OS was 13
months vs. 17.5 months, respectively. None of these
differences were significant. Toxicities of grade 3 or higher
were neutropenia (9.0% vs. 0%, respectively) and diarrhea
(13.6% vs. 0%, respectively). Conclusion: This genotypeoriented
therapy was effective and safe, and thus appears
useful for patients who have complications or advanced age.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 03 | Day |
Last modified on
| 2013 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005962
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| Registered date | File name |
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| Registered date | File name |
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