UMIN-CTR Clinical Trial

Public title

Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies

Acronym

Phase II study of S-1 plus bevacizumab as the third-line therapy in advanced colorectal cancer (CCOG-1105; C3-03 study)

Scientific Title

Multicenter phase II study of adding bevacizumab to oral S-1 therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies

Scientific Title:Acronym

Phase II study of S-1 plus bevacizumab as the third-line therapy in advanced colorectal cancer (CCOG-1105; C3-03 study)

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of oral S-1 plus bevacizumab therapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 plus bevacizumab 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Histopathologically confirmed colorectal cancer.
(2) Unresectable advanced colorectal cancer patients who have failed prior oxaliplatin- and irinotecan-based therapies with bevacizumab.
(3) Measurable or evaluable disease (RECIST ver.1.1.).
(4) Colorectal cancer with Kras mutant type gene.
(5) Age of 20 years or older.
(6) ECOG performance status 0-1.
(7) Life expectancy greater than 3 months.
(8) Written informed concent.
(9) Adequate organ function.

Key exclusion criteria

(1) Uncontrolled infection.
(2) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(3) Previous history of thoromboembolitic disease, or necessity for antithrombotic drug.
(4) Severe lung disease.
(5) Interstitial lung disease or pulmonary fibrosis.
(6) Severe liver disease.
(7) Severe renal failure, or urinary protein (more than 2+).
(8) Previous history of severe drug-induced allergy
(9) Intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer.
(10) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.).
(11) History of active double cancer.
(12) Massive pleural effusion or ascites that required drainage.
(13) Brain metastasis
(14) Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks or aspiration biopsy within a week.
(15) Diathesis of bleeding (history of hemoptysis, including cavitation and/or necrosis in lung metastasis confirmed by imaging), coagulopathy.
(16) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(17) Not appropriate for the s

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Goro Nakayama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan

TEL

052-744-2253

Email

goro@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Takahiro Asada, Koji Torii

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan

TEL

(81)52-744-2250

Homepage URL

http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/

Email

goro@med.nagoya-u.ac.jp

Institute

Cubu Clinical Oncology Group (CCOG)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

10

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011

Year

09

Month

26

Day

Date of IRB

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

05

Day

Last modified on

2016

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007687