UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000443
Receipt number R000000526
Scientific Title Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer
Date of disclosure of the study information 2006/07/04
Last modified on 2018/10/15 13:12:31

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Basic information

Public title

Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

Acronym

SOX

Scientific Title

Phase I/II study of the combination of Oxaliplatin and S-1 in patients with advanced/recurrent colorectal cancer

Scientific Title:Acronym

SOX

Region

Japan


Condition

Condition

unresectable advanced/recurrent colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of L-OHP combined with S-1 in patients with advanced/recurrent colorectal cancer, and to evaluate safety and clinical response with this therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Step1:safety;adverse events

Step2:Disease control rate

Key secondary outcomes

Step1:Eficacy (response rate(CR+PR),disease control rate, survival

Step2: Safety, Response rate, survival


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

S-1 is administered orally at the dose of 40mg/m2 twice a day for 21 days, followed by 7-14 days rest.
L-OHP is administered intravenously biweekly(day 1 and 15).
On 2nd steps L-OHP is administered with RD intravenously biweekly more than 2 courses.
The doses of L-OHP are 70mg/m2 for level 1, 85mg/m2 for level 2, and 55mg/m2 for level 0.

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) With histologically or cytologically confirmed colorectal cancer
2) unresectable disease
3) Patients who have measurable lesions with RECIST criteria
4) Previous treatment with one regimens is allowed. At least 4 weeks interval from the last administration of previous chemotherapy
5) Age 20 to 74 years.
6) PS 0-1(ECOG).
7) Life-expectancy is more than 3 months
8) Adequate organ functions (bone marrow, liver, heart, lung, kidney etc.). Patients are required to satisfy all of the next-mentioned criteria:
WBC > 4000/mm3 and <12000/mm3,
Granulocyte count > 2000/mm3,
Platelet count > 100,000/mm3,
Hb > 9.0 g/dl
AST & ALT < * 2.5 upper normal limit, Total bilirubin < 1.5mg/dl
Serum creatinine < upper normal limit
Cockroft-Gault CCr > 50ml/min
9) Written informed consent prior to the enrollment of the study.
10) adequate oral intake

Key exclusion criteria

1) during flucytosine medication
2) Active infection or inflammation
3) Uncontrolled severe Diabtes
4) patient severe medical condition
5) patient with interstitial pneumonitis or the history
6) patient with active gastrointestinal bleeding
7) patient with severe neurotoxicity
8) patient with active chicken pox
9) patient with metastasis of CNS
10) patient with other concurrent malignancy affecting on survival or adverse events
11) pregnant or nursing patient or with intent to bear baby
12) patient with allergic history to drug
13) patient with massive effusion of massive ascites
14) patient evaluated to be inadequate by a attending doctor

Target sample size

42


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigemi Matsumoto

Organization

Kyoto University Hospital

Division name

Outpatient Oncology Unit

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan

TEL

075-751-4770

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shigemi Matsumoto

Organization

Kyoto University Hospital

Division name

Outpatient Oncology Unit

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-ku, kyoto 606-8507, Japan

TEL

075-751-4770

Homepage URL


Email

motocame@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Outpatient Oncology Unit
Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

2006 Year 07 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

Terminated

Date of protocol fixation

2006 Year 03 Month 23 Day

Date of IRB


Anticipated trial start date

2006 Year 05 Month 01 Day

Last follow-up date

2009 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2006 Year 07 Month 04 Day

Last modified on

2018 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name