UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014892
Receipt number R000017318
Scientific Title Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation
Date of disclosure of the study information 2014/09/01
Last modified on 2014/08/19 13:23:29

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Basic information

Public title

Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation

Acronym

Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation

Scientific Title

Phase II study of TS-1+CPT-11+BV followed by TS-1+L-OHP+BV in unresectable advanced colorectal cancer with RAS mutation

Scientific Title:Acronym

Phase II study of IRIS+BV followed by SOX+BV in advanced colorectal cancer with RAS mutation

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of 1st line SOX+BEV and 2nd line IRIS+BEV sequential therapy for unresectable advanced and recurent colorectal cancer with RAS mutation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Second progression free survival

Key secondary outcomes

.Overall survival
.Transfer ratio of 2nd line chemotherapy
.Term of 1st line chemotherapy to 2nd line chemotherapy
Each of the 1st line and 2nd line chemotherapy
.Progression Free Survival: PFS
.Time to treatment failure: TTF
.Relative dose intensity: RDI
.Response Rate

.Frequency and Grade of Adverse Event
.Term of hospitalization and frequency of visiting the hospital
.Biomarker analysis


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

SOX+BEV and IRIS+BEV sequential therapy

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Histologocally or cytologycally proved colorectal cancer(adenocarcinoma)
2)Unresectable advanced or recurrent colorectal cancer
3)RAS mutated type
4)Elder than 20years of age
5)ECOG performance status of 0-1
6)Measureable region evaluable according to the RECIST of Computed Tomography or Magnetic Reasonance Image or X-ray within 30days
7)Previously no chemotherapy and no radiation therapy in case of postoperative adjuvant chemotherapy passed more 180days
8)Possible oral intake
9)Laboratory data within 14days satisfies the following conditions
1.WBC => 3,000 /mm3, WBC=<12,000 /mm3
2.Neutrophil =>1,500 /mm3
3.Platelet => 100,000 /mm3
4.hemoglobin concentration => 9.0 g/dl
5.Total bilirubin <= 2.0 mg/dl
6.AST or ALT <= 100IU/L
7.AST or ALT <= 200IU/L with liver metastasis
8.Ccr>= 60mL/min with an actual measurement in 24hr.
Without measurement to use Cockcroft-Gault Ccr=[(140-age)*body weight]/[72*serum cre](if female 0.85*)
9.Uric protein<=1+
10.INR <=1.5
10)Life expectancy of at least 3months
11)Written informed consent

Key exclusion criteria

1)Presence of severe drug allergy
2)Pregnant patients
3)Active infection(>=38.0C)
4) Presence of severe complication(interstitial pneumonia or lung fibrosis, renal failure, liver failure, Poorly controlled diabetes mellitus poorly controlled hypertension
5) Remarkable ECG change or clinical heart disease (heart failure, AMI, angina)
6) Active gastric bleeding or gastric ulcer
7) Peripheral neuropathy
8) Severe diarrhea
9) Pleural effusion or ascites needed to treat
10) Gastrointestinal perforation in 6 months (without obstractive colorectal cancer)
11) Thromboembolism or cerebral infarction(without asymptomatic lacunar infarction ), pulmonary infraction, intestinal pneumonia
12) Operation within 28days (an exception of implanting central venous reservoir)
13) Congenital hemorrhagic diathesis or coagulopathy
14) Other active malignancies
of DFS is within 5years (except for the case skin basal carcinoma and cervical cancer be cured or Stomach cancer, esophageal cancer, colorectal pM cancer that was confirmed cured by an endoscopic treatment)
15) Needed to dosage systemic steroid
16) Evaluated to be ineligible by a physician for other reasons
17) Hemoptysis( more than 2.5ml)
18) Contraindication of L-OHP ,CPT-11, BV , TS-1
19) Primary tumor with severe stenosis that an endoscope does not pass(Except for the case that constructed excision of the primary tumor or the artificial anus)
20) Peritoneum metastasis confirmed with an image.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi Furukawa

Organization

Department of Gastroenterology & Hepatology, Niigata City General Hospital

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

463-7 Kaneki Chuohku, Niigata, 951-8510 Japan

TEL

0252815151

Email

furukawa@hosp.niigata.niigata.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuo Saijo

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Department of Medical Oncology

Zip code


Address

1-757 Asahimachidori Chuohku, Niigata, 951-8510 Japan

TEL

0253689004

Homepage URL


Email

yasosj@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata Colorectal Cancer Study Group

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

新潟市民病院、新潟大学医歯学総合病院、新潟県立がんセンター新潟病院、長岡中央病院


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 01 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 01 Day

Last follow-up date

2019 Year 06 Month 01 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 08 Month 19 Day

Last modified on

2014 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name