UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024323
Receipt number R000027398
Scientific Title The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-
Date of disclosure of the study information 2016/10/06
Last modified on 2016/10/06 20:29:47

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Basic information

Public title

The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

Acronym

The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

Scientific Title

The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

Scientific Title:Acronym

The efficacy and safety of perioperative chemotherapy for locally advanced colorectal cancer. - The phase II study-

Region

Japan


Condition

Condition

locally advanced colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and the safety of first line chemotherapy for locally advanced colorectal cancer with RAS wild and mutation type.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate (judged by enhanced CT and MRI on 12 weeks after initiation of chemotherapy)

Key secondary outcomes

Induction rate of curative operation, Overall survival, Relapse free survival. Incidence rate of complication


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

1) All RAS wild-type: 6 courses of cetuximab+mFOLFOX6 or 4 courses of cetuximab+SOX is performed, followed by curative operarion.
2) All RAS mutant-type: 6 courses of FOLFOXIRI or SOXIRI is performed, followed by curative operation.

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Written informed consent
2) Investigator determines that the appropriate
3) Histologically confirmed colorectal cancer(Excluding the appendix)
4) RAS wild-type or mutant.
5) With measurable lesion
6) Irinotecan case of use UGT1A1 *6 *28 is a wild type or single hetero.
7) Without chemotherapy history (Including the hepatic arterial infusion / radiation therapy). However, with regard to the post-operative adjuvant chemotherapy, to be registered if it passed more than 6 months from the end of treatment.
8) Performance Status (ECOG) 0-2 (Possible outpatient treatment)
9) Age over 20 years
10) Survival period more than 3 months
11) Adequate organ function (Inspection of within 14 days before)
1. WBC: >=3000/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: <=1.5mg/dL
12) With ability of oral intake

Key exclusion criteria

1) Patients with severe drug allergy (hypersensitivity)
2) Clinical problem infection
3) Liver dysfunction (jaundice) / Severe renal dysfunction
4) Uncontrolled high blood pressure, Diabetes, Hypercalcemia
5) Severe lung disease (Interstitial pneumonia, Pulmonary fibrosis, Advanced emphysema, etc)
6) Patient who need drainage of peritoneal, pleural or pericardial effusion.
7) Brain metastases (Diarrhea a hindrance to daily life in the patient who has a colostomy)
8) Diarrhea (watery stool)
9) Hepatitis B / C virus-positive

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuji Tokuhara, MD

Organization

Kansai Medical University Medical Center

Division name

Department of Surgery

Zip code


Address

10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan

TEL

06-6992-1001

Email

tokuhark@takii.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuji Tokuhara, MD

Organization

Kansai Medical University Medical Center

Division name

Department of Surgery

Zip code


Address

10-15 Fumizono-cho, Moriguchi Osaka, 570-8507, Japan

TEL

06-6992-1001

Homepage URL


Email

tokuhark@takii.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University Medical Center

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2016 Year 10 Month 06 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

2016 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 26 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

2016 Year 10 Month 06 Day

Last modified on

2016 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027398


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name