UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007834
Receipt number R000008819
Scientific Title A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
Date of disclosure of the study information 2012/05/11
Last modified on 2019/01/07 16:58:31

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Basic information

Public title

A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Acronym

A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
(TRICOLORE)

Scientific Title

A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer

Scientific Title:Acronym

A randomized phase III study of oxaliplatin based chemotherapy versus combination chemotherapy of TS-1,irinotecan and bevacizumab as first line therapy for unresectable or recurrent colorectal cancer
(TRICOLORE)

Region

Japan


Condition

Condition

unresectable or recurrent colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the non-inferiority and superiority of TS-1/irinotecan + bevacizumab therapy against 5-FU/l-LV/oxaliplatin(mFOLFOX6) + bevacizumab therary or capecitabine/oxaliplatin(CapeOX) + bevacizumab therapy in progression free survival for unresectable advanced/recurrent colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

Progression free survival(PFS)

Key secondary outcomes

Overall survival(OS)
Response rate(RR)
Time to treatment failure(TTF)
Relative dose intensity(RDI)
Safety
Quality of life(QOL)
Quality adjusted life years(QALY)
Health economics
Translational research


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

arm A-1:mFOLFOX6+Bevacizumab

Bevacizumab 5mg/kg/bi-week
L-OHP 85mg/m2/bi-week
l-LV 200mg/m2/bi-week
5-FU/bolus 400mg/m2/bi-week
5-FU/infusional 2,400mg/m2/bi-week

arm A-2: CapeOX+Bevacizumab

Bevacizumab 7.5mg/kg/tri-week
L-OHP 130mg/m2/tri-week
Capecitabine 1200-2100mg/twice/day(day 1-15)

Interventions/Control_2

arm B-1:TS-1/CPT-11+Bevacizumab(SIRB)

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

arm B-2:TS-1/CPT-11+Bevacizumab(IRIS/BV)

Bevacizumab 5mg/kg/(day1and15)/4-weeks
CPT-11 100mg/m2/(day1and15)/4-weeks
S-1 40-60mg/twice/day(day1-15)/4weeks

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.Histologically proven colorectal cancer (Adenocarcinoma)
2.Unresectable advanced/recurrent colorectal cancer
3.Aged over 20 years at the time of registration
4.Performance status(ECOG) :0,1
5.Patients with evaluable lesion
6.Previously not treated (chemotherapy, radiotherapy, etc.) for unresectable colorectal cancer
7.Able to receive oral treatment
8.Adequate organ function
9.Life expectancy estimated>=3 months
10.Written IC

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.Serious complications
5.Significant abnormal ECG or history of cardiovascular disease
6.Peptic ulcers
7.Peripheral neuropathy
8.Watery diarrhea
9.Massive pleural effusion or ascites
10.Mechanical bowel obstruction
11.Symptomatic peritoneum dissemination
12.Brain metastasis
13.Current or previous (within the last 6 months) history of GI perforation
14.Hemoptysis (=> 2.5ml)
15.Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
16.Any surgical treatments within 28 days
17.Evidence of bleeding diathesis or coagulopathy
18.Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
19.Administering transfusion within 14 days
20.Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
21.Under coutinuous steroid administration
22.Active hepatitis type HBs positive
23.Administration contraindication of 5-FU, Leucovorin, Capecitabine, TS-1, Oxaliplatin, CPT-11 and Bevacizumab
24.Any other cases who are regarded as inadequate for study enrollment by the investigator

Target sample size

450


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chikashi Ishioka(1), Yoshito Komatsu(2), Ken Shimada(3), Tatsuro Yamaguchi (4)

Organization

Institute of Development, Aging and Cancer, Tohoku University(1)
Hokkaido University Hospital(2)
Showa University Kouto Toyosu Hospital(3)
Komagome Hospital(4)

Division name

Department of Clinical Oncology (1), Cancer Center (2), Department of Medical Oncology (3), Department of Surgery,Hereditary Tumor Research Project(4)

Zip code


Address

4-1 Seiryo-cho Aoba-ku Sendai Miyagi (1), N14 W5 Kita-ku Sapporo Hokkaido (2), 5-1-38 Toyosu,Kouto-ku (3), 3-18-22 Honkomagome, Bunkyo-ku, Tokyo (4)

TEL

03-5401-5020

Email

tricolore@tcog.jp


Public contact

Name of contact person

1st name
Middle name
Last name TRICOLORE study affairs office

Organization

The Tokyo Cooperative Oncology Group

Division name

Clinical Study Promotion Agency

Zip code


Address

2-1-18 Hamamatsu-cho Minato-ku Tokyo

TEL

03-5401-5020

Homepage URL


Email

tricolore@tcog.jp


Sponsor or person

Institute

The Tokyo Cooperative Oncology Group

Institute

Department

Personal name



Funding Source

Organization

TAIHO PHARMACEUTICAL CO.,LTD

Organization

Division

Category of Funding Organization

Profit organization

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

2012 Year 05 Month 11 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdx816/4779925

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

2012 Year 04 Month 13 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2012 Year 04 Month 25 Day

Last modified on

2019 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008819


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name