UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032102
Receipt number R000036626
Scientific Title Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy
Date of disclosure of the study information 2018/04/04
Last modified on 2018/04/04 20:04:40

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Basic information

Public title

Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy

Acronym

Study of resection of primary colorectal caner and synchronous liver metastasis after SOX + Bmab

Scientific Title

Phase II study of resection of primary colorectal caner and synchronous liver metastasis after S-1 + oxaliplatin (SOX) + Bevacizumab(Bmab) therapy and adjuvant S-1 chemotherapy

Scientific Title:Acronym

Study of resection of primary colorectal caner and synchronous liver metastasis after SOX + Bmab

Region

Japan


Condition

Condition

Colorectal cancer with synchronous liver metastasis

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to examine the efficacy and safety of resection of primary colorectal cancer and synchronous liver metrastasis after S-1 + oxaliplatin + bevacizumab and adjuvant S-1 chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

progression free survival

Key secondary outcomes

Overall survival, Relapse-free survival, R0 rate of primary tumor, R0 rate of liver metastasis, Reoperation rate, Completion rate of S-1 + oxaliplatin + bevacizumab, Safety, Efficacy


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 Maneuver

Interventions/Control_1

S-1 is administered orally at 80mg/m2/day for 14 consecuitive days followed by a 7 day rest. L-OHP is given intravenously on days 1, at a dose of 130mg/m2/day.Bevacizumab is given intravenously on days 1, at a dose of 7.5mg/kg/day. 21 days are assumed 1 course, and chemotherapy consisted of 4 courses. Surgery is carried out in 8 to 12 weeks after the end of chemotherapy.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

"1) Histologically confirmed Rectum adenocarcinoma
2) Adequate following in the diagnostic imaging within 28 days before registration
1. Clinical stage T3, any N, or T4, any N
2. The edge of tumor is lower than Ra, Rb, P (Within 12cm from anal verge)
3. Unresectable rectal cancer by organ-sparing TME which was judged by high resolutoin MRI
-CRM<=1mm
-T4b
-Lateral lymph node metastasis
3) Without liver, peritoneum and distant metastases
4)Age of 15-75 years
5)Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy)
6)Aadequate function of important organs
1. WBC: >=3,000/mm3 and 12,000/mm3
2. Neutrophil: >=1,500/mm3
3. Platelet: >=100,000/mm3
4. Hemoglobin: >=9.0g/dL
5. T Bil: <=2.0mg/dL
6. AST, ALT: <100IU/L
7. Serum creatinine: <=1.2mg.DL
8. Creatinin clearance level >= 60mi/min
9. Urine protein<=1+
10. INR<=1.5
7) ECG: without clinically problematic abnormalities within 28 days before registration
8) Eastern Cooperative Oncology Group performance status (PS) 0-1
9) With ability of oral intake
10) Written informed concent "

Key exclusion criteria

"1) with gastrointestinal ulceration or bleeding
2) with sensory neuropathy
3) with severe diarrhea
4) had a previous serious drug allergies
5) had pleural effusion or ascites which need therapy
6) with brain metastasis or suspected the brain metastases
7) had surgery within 28 days before registration
8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
10) with active double cancer
11) had active infection disease (over 38.0 degree)
12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris)
13) receiving Flucytosine
14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant
15) had hemoptysis (2.5 ml or more of fresh blood)
16) had gastrointestinal perforation within 6 months
17) were systemically-administered of steroids
18) with contraindications to TS-1, L-OHP, and Bevacizumab
19) with HBsAg-positive
20) Physician will determine that the patient is inappropriate participate in this trail for the safety. "

Target sample size

28


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime Morohashi

Organization

Hirosaki University Graduate School of Medicine

Division name

Gstroenterological Surgery

Zip code


Address

5 Zaifu-chou, Hirosaki, Aomori, Japan

TEL

0172-39-5079

Email

hm2002@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hajime Morohashi

Organization

Hirosaki University Graduate School of Medicine

Division name

Gstroenterological Surgery

Zip code


Address

5 Zaifu-chou, Hirosaki, Aomori, Japan

TEL

0172-39-5079

Homepage URL


Email

hm2002@hirosaki-u.ac.jp


Sponsor or person

Institute

Aomori Colorectal Cancer Study (ACCS) 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

2018 Year 04 Month 04 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

2018 Year 02 Month 14 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 01 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

2018 Year 04 Month 04 Day

Last modified on

2018 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036626


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name