UMIN-CTR Clinical Trial

Public title

Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer

Acronym

Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer

Scientific Title

Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer

Scientific Title:Acronym

Phase II trial of capecitabine + bevacizumab as maintenance treatment after initial treatment with XELOX in previously untreated metastatic colorectal cancer

Region

Japan

Condition

advanced colorectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study is designed to evaluate efficacy and safety of both Capecitabine + Bevacizumab as maintenance treatment after initial treatment with XELOX + Bevacizumab and reintroduction of oxaliplatin after Capecitabine + Bevacizumab as maintenance treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Duration of disease control

Key secondary outcomes

Progression Free Survival,Time to Treatment Failure,Safety,Overall Response Rate,2nd Overall Response Rate,Reintroduction rate of Oxaliplatin,Overall Survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive XELOX(+BEV) for 4 cycles, they then receive XEL+BEV until PD, they finally receive XELOX(+BEV) until PD.

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)Histological confirmation of colorectal cancer.
(2)Written informed consent.
(3)20 years old or more when received informed consent.
(4)Eastern Cooperative Oncology Group (ECOG) Performance Status(PS):0-2.
(5)Life expectancy estimated 3 months, and more.
(6)Measurable lesions in RECIST criteria (ver.1.1) is needed.
(7)Patients with metastatic colorectal cancer who had received no previous therapy.Previous adjuvant treatment is allowed if it is completed at least 6 months before registration.
(8)Patients with advanced colorectal cancer who had received no intervention expect surgical procedure(R0 surgery is not included).
(9)Patients with recurrent colorectal cancer who have not been administered any therapy to the recurrent site.
(10)Vital organ functions (listed below) are preserved within 14 days prior to entry.
1. White blood cell count >= 4,000 /mm3
2. Platelets >= 100,000 /mm3
3. Hemoglobin >= 9.0 g/dL
4. Total bilirubin >= 1.5 mg/dL
5. AST,ALT <= 100 IU(<= 200 IU in liver metastases case)
6. Serum creatinine <= upper limit of normal (ULN)
7. Urinary protein <= Grade1(1+ or 0.15-1 g/24hr)

Key exclusion criteria

(1)History of the serious hypersensitivity for Capecitabine, Fluorouracil, Platinum or bevacizumab.
History of the serious AE for Capecitabine or Fluorouracil by DPD Deficiency.
(2)CNS metastases or brain cancer confirmed by imaging.
(3)Cerebrovascular disease or its symptoms within 1 year.
History of thromboembolism once within a year.
(4)Synchronous malignant coelomic fluid that required drainage.
(5)History of active double cancer within 5 years.
(6)Necessity for antithrombotic drug.
(7)Need tobadministrate or having anti-plateles therapy(including Methotrexate, aspirin and NSAIDS)
(8)Symptom of gastrointestinal bleeding, intestinal paralysis, ileus, uncontrolled complication of peptic ulcer.
(9)History of gastrointestinal perforation within 1 year.
(10)Evidence of traumatic bone fracture.
(11)Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry.
(12)Uncontrolled hypertension or diabetes.
(13)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.
(14)Evidence of interstitial lung disease or lung fibrosis.
(15)Evidence of peripheral sensory neuropathy(>=Grade 1 according to NCI-CTCAE ver.4).
(16)Uncontrolled infection.
(17)Patient receiving surgical procedure or such as skin-open biopsy, trauma surgery, or other more intensive surgeries within 4 weeks.
(18)Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(19)Man who doesn't practice birth control.
(20)Not appropriate for the study at the physician's assessment.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Sugimoto

Organization

Shimane Prefectural Central Hospital

Division name

Department of Surgery

Zip code

Address

4-1-1 Himehara, Izumo city

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Shimane Prefectural Central Hospital

Division name

Department of Surgery

Zip code

Address

TEL

Homepage URL

Email

shin1028@spch.izumo.shimane.jp

Institute

SGCSG: Shimane Gastroenterological Cancer Study Group

Institute

Department

Personal name

Organization

SGCSG: Shimane Gastroenterological Cancer Study Group

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

08

Month

03

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

Open public recruiting

Date of protocol fixation

2011

Year

04

Month

18

Day

Date of IRB

Anticipated trial start date

2011

Year

07

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

08

Month

03

Day

Last modified on

2013

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007226