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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000951
Receipt No. R000001143
Scientific Title Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer
Date of disclosure of the study information 2007/12/19
Last modified on 2015/10/21

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Basic information
Public title Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer
Acronym KODK7 RPII
Scientific Title Randomized phase II trial of irinotecan(CPT-11) plus tegafur/uracil with oral leucovorin(UFT/LV) compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer
Scientific Title:Acronym KODK7 RPII
Region
Japan

Condition
Condition Patients with previously untreated and unresectable/recurrent colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of CPT-11 plus UFT/LV compared with FOLFIRI in patients with unresectable/recurrent colorectal cancer at random as clinical phase 2 study.
Although the trial allow to use Bevacizumab together if the patient hope that, the group treated by Bevacizumab will be interrupted the entry when the enrollments run into 6 in each group and evaluate the toxicity (step 1).
When the step 1 trial will be finished and be confirmed the safety of Bevacizumab, get into the Step 2 and evaluate the efficacy and toxicity(step 2).

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Step1 Toxicity
Step2 Progression-free survival

Key secondary outcomes Step2 Response rate, toxicity, Time to treatment failure, overall survival


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest.
CPT-11 150mg/m2/day is given intravenously on day 1 and 15 of each cycle.
Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.
Interventions/Control_2 The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occuring disease progression or severe toxicities.FOLFIRI consisted of CPT-11 150 mg/m2 IV over 90 minutes, LV 400 mg/m2 IV over 2 hours, and FU 400 mg/m2 IV bolus, followed by FU 2.400mg/m2 IV over a 46-hour infusion, repeated every 2 weeks.
Cycles are repeated every 4 weeks, until evidence of disease progression or severe toxicities.
Interventions/Control_3 UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive day followed by a 7 days rest.
CPT-11 and Bevacizumab are given intravenously on day 1 and 15 of each cycle.
Bevacizumab is added dilute to 100mL with physiological salt solution and given intravenously over 90 minutes. After the tolerability of the initial administration time is confirmed, the time can be shortened to 60 minutes.
After the tolerability of the second administration time is confirmed, the time can be shortened to 90 minutes.
After the administration of Bevacizumab, CPT-11 150mg/m2/day is given
Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities.
Interventions/Control_4 The administration is done on the 1st day and the 15th day of each cycle. Cycles are repeated every 4 weeks, until occurring disease progression or severe toxicities. Bevacizumab is added dilute to 100mL with physiological salt solution and given intravenously over 90 minutes. When the tolerability of the initial administration time is acceptable, then the time can be shortened to 60 minutes.
After the tolerability of the second administration time is confirmed, the time can be shortened to 90 minutes.
5-FU and CPT-11 is given as follows.
FOLFIRI consists of CPT-11 150 mg/m2 over 90 minutes, LV 400 mg/m2 over 2 hours, and FU 400 mg/m2 bolus, followed by FU 2.400mg/m2 over a 46-hours infusion, repeated every 2 weeks.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)colorectal cancer proven histologically
2) with measurable metastatic lesions
3) without prior chemotherapy or with chemotherapy which is completed before 6 months of registration
4) age: >=20 and <=75
5)Performance Status: 0-1 (ECOG)
6)more than 3 months of expected survival period
7)sufficient function of important organs
a) WBC: >=3,500/mm3 and <12,000/mm3
b) Neutrophyl: >=2,000/ mm3
c) Platelet: >=100,000/ mm3
d) Hemoglobin: >=9.0 g/dl
e) GOT, GPT: 2.5 times of normal range in each institute
f) sT.bil: <=1.5 mg/dl
g) sCreatinin: <=1.5 mg/dl
h) normal ECG
8)written informed consent
9)with ability of oral intake
Key exclusion criteria 1)with history of myocardial infarction, drug hypersensitivity within 6 months prior to the registration.
2) Prior ventral irradiation for colorectal cancer.
3)with active infection.
4)with intestinal paralysis, intestinal obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, liver dysfunction, which disturb registration to this study.
5) Massive pleural or ascites that required drainage.
6)with brain metastasis.
7)with diarrhea.
8)with active double cancer.
9)patients receiving Flucytosine or Atazanabil.
10)with mental disorder which disturbs registration to this study.
11)pregnant or nursing women or women who like be pregnant.
12)men with partner willing to get pregnant.
13)patients receiving analgesic drug or steroids.
14)doctor's decision not to be registered to this study.
In addition to the above-mention, patients who hope to use Bevacizumab together has to be checked about the following factors.
1)Urine dipstick for proteinuria should be <2+
2)Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism.
3)Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks.
4) History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
5) Long-term daily treatment with aspirin (>325 mg/day)
6) History of evidence of bleeding tendency or coagulopathy or defect of coagulation factor (INR>=1.5) or patient who taking anticoagulant agent.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Hasegawa
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582
TEL 03-3353-1211
Homepage URL
Email forum04@sc.itc.keio.ac.jp

Sponsor
Institute Department of Surgery, School of Medicine, Keio University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2007 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2007 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2015 Year 06 Month 15 Day
Date of closure to data entry
2015 Year 06 Month 15 Day
Date trial data considered complete
2015 Year 06 Month 15 Day
Date analysis concluded
2015 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 19 Day
Last modified on
2015 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001143

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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