UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007931
Receipt number R000009304
Scientific Title Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer
Date of disclosure of the study information 2012/05/11
Last modified on 2015/05/18 19:00:15

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Basic information

Public title

Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer

Acronym

Relief Trial

Scientific Title

Phase2 trial of Preoperative chemotherapy with XELOX prus Bv for resectable liver metastases from colorectal cancer

Scientific Title:Acronym

Relief Trial

Region

Japan


Condition

Condition

colon cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of XELOX + bevacizumab (4 cycles) followed by liver resection for liver limited disease (H1, H2) from metastatic colorectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

disease control rate

Key secondary outcomes

response ratetumor regression grade1-3.Tumor Regression Grade1-3.progression-free survival.relapse-free survival.R0 liver resection rate.adverse events.postoperative complications.sinusoidal dilatation.ICG R15 fluctuation.sub-group analysis by Kras mutational status


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

Treatment is administered every 3 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for 4 cycles.

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.colorectal cancer,cytologically and/or
2. synchronous or metachronous liver metastases
*no prior treatment for liver metastases
3.no extra hepatic metastases
4.no prior treatment for liver metastasis
5.at least one or more measurable lesions of liver metastases
6.6 months or later after last dose of oxalipatin as adjuvant chemotherapy following primary resection
7.age: 20- years old
8.ECOG PS: 0-1
9.witten informed consents
10.sufficient organ functions

Key exclusion criteria

1.clinical or radiological evidence of CNS metastases.
2. current or previous (within the last 1 year) history of cerebrovascular disease
3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0
4.serious non-healing fracture
5.current or previous (within the last 1 year) history of GI perforation
6.serious non-healing ulcer
7.evidence of bleeding diathesis or coagulopathy.
8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes
9.ongoing treatment with aspirin (> 325 mg/day)
10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
11.uncontrolled hypertension
12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment
13.uncontrolled pleural and/or peritoneal effusion
14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:
- Basal and squamous cell carcinoma of the skin
- In-situ carcinoma of the cervix
15.interstitial lung disease, or pulmonary fibrosis
16.uncontrolled infection
17.history of organ
18. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3.
19.pregnancy (positive serum pregnancy test) and lactation
20.serious drug hypersensitivity or a history of drug allergy
21.history of adverse events related to fluorouracil
22.with liver cirrhosis and/or Viral hepatitis
23.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahito Kotaka

Organization

Sano Hospital

Division name

Gastrointestinal Center

Zip code


Address

Shimizugaoka 2-5-1, Tarumi-ku, Kobe

TEL

078-785-1000

Email

tomomakotaka6410@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Hashida

Organization

Kobe City Medical Center General Hospital

Division name

Surgery

Zip code


Address

Minatojimaminami-cho 2-1-1,chuo-ku, Kobe

TEL

078-302-4321

Homepage URL


Email

hhashida@kcho.jp


Sponsor or person

Institute

Sano HospitalGastrointestinal Center

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

2012 Year 05 Month 11 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

2012 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 05 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

2012 Year 05 Month 11 Day

Last modified on

2015 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009304


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name