UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015098
Receipt number R000017566
Scientific Title Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab
Date of disclosure of the study information 2014/09/09
Last modified on 2019/10/07 14:49:57

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Basic information

Public title

Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab

Acronym

Phase II study of IRIS+BV as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX + BV

Scientific Title

Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab

Scientific Title:Acronym

Phase II study of IRIS+BV as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX + BV

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of IRIS+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX+Bmab

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Response rate (RR)
Time to treatment failure (TTF)
Overall Survival (OS)
Safety profile
Relative dose intensity(RDI)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab 7.5mg/kg/tri-week
CPT-11 150mg/m2/tri-week
S-1 40-60mg/twice/day(day1-15)/tri-week

Interventions/Control_2


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

1.Histologically proven colorectal cancer (Adenocarcinoma)
2.Unresectable advanced/recurrent colorectal cancer
3. A measurable lesions in RECIST criteria is unnecessary
4. Metastatic colorectal cancer refractory to S-1, oxaliplatin, and Bmab therapy as first-line
5. Chemotherapy without 2 weeks before the initial administration of the study drug
6. Previously not treated radiotherapy for unresectable colorectal cancer
7. Aged 20-80 years at the time of registration
8. Performance status(ECOG) :0,1
9.Life expectancy estimated>=3 months
10.Adequate organ function
11. No abnormally electrocardiogram
12. Written IC
13. Able to receive oral treatment

Key exclusion criteria

1. History of serious drug hypersensitivity
2. Pregnant, lactating or women of
child-bearing potential. Men who want get partner pregnant.
3. Active infections 4.
4. Serious complications
5. Peptic ulcers
6. Over grade 2 diarrhea
7. Massive pleural effusion or ascites
8. Mechanical bowel obstruction
9. Symptomatic peritoneum dissemination
10. Brain metastasis
11. Current or previous (within the last 6 months) history of GI perforation
12. Hemoptysis
13. Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
14. Evidence of bleeding diathesis or coagulopathy
15. Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
16. Administering transfusion within 14 days
17. Other active malignancies
18. Administration contraindication of 5-FU(Capecitabine, TS-1) Oxaliplatin, CPT-11 and Bevacizumab
19. Any other cases who are regarded as inadequate for study enrollment by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Kuwano

Organization

Gunma University Graduate School

Division name

Department of General Surgical Science

Zip code


Address

3-39-22 Showa-machi, Maebashi-shi, Gunma

TEL

027-220-8224

Email

hkuwano@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Soichi Tsutsumi

Organization

Gunma University Graduate School

Division name

Department of General Surgical Science

Zip code


Address

3-39-22 Showa-machi, Maebashi-shi, Gunma

TEL

027-220-8224

Homepage URL


Email

chuchumi@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Graduate School

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

2014 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Completed

Date of protocol fixation

2013 Year 09 Month 20 Day

Date of IRB

2014 Year 06 Month 25 Day

Anticipated trial start date

2014 Year 06 Month 25 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 09 Day

Last modified on

2019 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name