UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000951
Receipt number 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 17:10:53

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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 or person

Institute

Department of Surgery, School of Medicine, Keio University

Institute

Department

Personal name



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

Value
https://center6.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