UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012618
Receipt number R000014438
Scientific Title Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.
Date of disclosure of the study information 2013/12/18
Last modified on 2018/12/21 15:15:53

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Basic information

Public title

Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.

Acronym

Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.(KSCC1303)

Scientific Title

Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.

Scientific Title:Acronym

Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.(KSCC1303)

Region

Japan


Condition

Condition

Colon cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of C-SOX as adjuvant chemotherapy for Stage III colon cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

3-years Disease free survival rate

Key secondary outcomes

The rate of completion of treatment as planned
Adverse event
Relative dose intensity
Disease free survival
Overall 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

Oxaliplatin 130 mg/m2 (day 1)
S-1 80-120 mg/day (day1-14)
to be repeated every 3 weeks.

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) Written informed consent
2) Patients who are judged to be suitable for receiving this protocol therapy by physician
3) Pathologically and Histologically confirmed colon adenocarcinoma
4) No prior chemotherapy and radiotherapy
5) Stage III, pathologically confirmed colon adenocarcinoma
6) R0 resection with D2 or D3 lymph node dissection was performed
7) Registration within 8 weeks after surgery
8) Age >= 20 years old
9) PS 0-1
10) Be able to take oral drugs
11) Recovery of postoperative complications
12) Required baseline laboratory parameters (within 14 days before registration):
i) Neu >= 1,500/mm3
ii) Hb >= 9.0g/dL
iii) Plt >= 100,000/mm3
iv) AST <= 100IU/L
v) ALT <= 100IU/L
vi) T-Bil < 2.0mg/dl
vii) Ccr >= 60mL/min

Key exclusion criteria

1) History of the severe hypersensitivity
2) Active other malignancies
3) Sensory neuropathy >= Grade 1
4) Diarrhea >= Grade 2
5) Active infections
6) History of mental disorder, central nerve disorder
7) Serious complication
8) Blood transfusion or hemopoietic factors (e.g. G-CSF) within 14 days
9) Pleural effusion, peritoneal fluid that needs treatment
10) Hemorrhagic diathesis, coagulation disorder
11) Patients who need flucytosine, phenytoin or warfarin potassium
12) Requiring steroid drug
13) Pregnant or lactating woman and man who hope for Partner's pregnant
14) Positive for HBs antigen and HCV antibody
15) Investigator's judgement

Target sample size

85


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoji Natsugoe

Organization

Kagoshima University

Division name

Department of Digestive Surgery, Breast and Thyroid Surgery

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-631-2920

Email

kscc2@cres-kyushu.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name KSCC

Organization

Clinical Research Support Center Kyushu

Division name

KSCC

Zip code


Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan

TEL

092-631-2920

Homepage URL


Email

kscc2@cres-kyushu.or.jp


Sponsor or person

Institute

Kyushu Study group of Clinical Cancer(KSCC)

Institute

Department

Personal name



Funding Source

Organization

Yakulto Honsha Co.

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 12 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 02 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

2013 Year 12 Month 18 Day

Last modified on

2018 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name