UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011680
Receipt number R000013519
Scientific Title Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC
Date of disclosure of the study information 2013/09/08
Last modified on 2016/11/16 09:07:21

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Basic information

Public title

Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC

Acronym

CCOG1002.1

Scientific Title

Multicenter Phese II Study of SOX plus Bevacizumab Therapy with Oxaliplatin Stop-and-Go Strategy and Oral S-1 plus Bevacizumab Maintenance Therapy in Advanced Colorectal CancerC

Scientific Title:Acronym

CCOG1002.1

Region

Japan


Condition

Condition

Unresectable metastatic or recurrent 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 SOX (S-1+L-OHP) plus bevacizumab therapy considering Oxaliplatin Stop-and-Go Strategy in Advanced Colorectal Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

DDC ; Duration of disease control)

Key secondary outcomes

TTF;Time to treatment-failure, PFS;Progression free-survival, OS;Overall survival, RR;Response rate, Reintroduction rate of SOX+bavacizumab therapy, safety


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

(1)Initial therapy
: SOX+bevacizumab therapy
Bev : 7.5 mg/kg (90 min)
L-OHP : 130 mg/m2 (120 min)
S-1 : 80 - 120 mg/day (Day1-15)
(2)Maintenance therapy
: S-1+bevacizumab therapy
Bev : 7.5 mg/kg (90 min)
S-1 : 80 - 120 mg/day (Day1-15)
(3)Reintroduced therapy
: SOX+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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Histopathologically confirmed colorectal cancer.
(2) Written informed consent.
(3) Age of 20 years or older.
(4) ECOG performance status 0-1.
(5) Life expectancy greater than 3 months.
(6) Measurable or evaluable disease (RECIST ver.1.1.).
(7) Untreated colorectal cancer.
(8) Unresectable advanced colorectal cancer patient who have received no treatment without operation.
(9) Reccurent colorectal cancer patient who have received no treatment for reccurence.
(10) Adequate organ function.

Key exclusion criteria

1) Previous history of severe drug-induced allergy.
2) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers, and man who wish to become his partner pregnancy.
3) Uncontrolled infection.
4) Uncontrolled severe complications (Interstitial lung disease, pulmonary fibrosis, renal failure, liver failure, DM, hypertension, et al.).
5) Patient with symptomatic cardiovascular disease or asymptomatic disease.
6) Patient who have peripheral nerve disorder.
7) Patient who have severe diarrhea.
8) Massive pleural effusion or ascites that required drainage.
9) Brain metastasis
10) History of Interstitial lung disease.
11) History of active double cancer.
12) Systemic administration of steroid.
13) Contraindication of S-1, L-OHP, Bevacizumab.
14) Not appropriate for the study at the physician's assessment.
15) Patient receiving surgical procedure within 28days.
16) History of gastrointestinal perforation within 6 months.
17) Patient who have gastrointestinal ulcer or bleeding.
18) Diathesis of bleeding or coagulopathy.
19) History of thoromboembolitic disease.
20) Patient with untreated traumatic bone fracture.
21) Systemic administration of antiplatelet drug, aspirin, and NSAIDS.
22) History of hemoptysis.
23) Colorectal cancer with obstruction.
24) Peritoneum dissemination confirmed by imaging

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Goro Nakayama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Gastroenterology

Zip code


Address

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

TEL

(81)52-744-2253

Email

goro@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miyuki Aoki

Organization

Chubu Clinical Oncology Group(CCOG)

Division name

Data center

Zip code


Address

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

TEL

(81)52-744-2253

Homepage URL

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

Email

goro@med.nagoya-u.ac.jp


Sponsor or person

Institute

Chubu Clinical Oncology 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



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 08 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

Enrolling by invitation

Date of protocol fixation

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 08 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=R000013519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name