UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006541
Receipt number R000007751
Scientific Title A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.
Date of disclosure of the study information 2011/10/14
Last modified on 2011/10/14 11:27:32

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Basic information

Public title

A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.

Acronym

A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.

Scientific Title

A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.

Scientific Title:Acronym

A randomized trial of postoperative adjuvant chemotherapy with capecitabine versus capecitabine/PSK following curative resection for stage III colon cancer.

Region

Japan


Condition

Condition

Colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate availability of postoperative immunochemotherapy using PSK, conduct a randomized controlled trial of postoperative adjuvant therapy with capecitabine versus capecitabine/PSK following curative resection for histological stage III colon cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events rate

Key secondary outcomes

3 years disease free survival, 3 years relapse free survival, 3 years overall survival, compliance, QOL


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Capecitabine treatment group
Group A (capecitabine group)
Protocol treatment starts within 6 weeks after surgery. Capecitabine is administrated dosage corresponding body surface area twice a day (within 30 minutes after breakfast and dinner) orally for 14 days followed by 7-days resting period without treatment (one cycle) for 8 cycles.

Interventions/Control_2

Capecitabine/PSK treatment group
Group B (capecitabine/PSK group)
Protocol treatment starts within 6 weeks after surgery. Capecitabine is administrated as group A. PSK is administrated orally each day (3g/day, three times a day) for 24 weeks. PSK is administrated with capecitabine in the mornings and evenings, and after lunch in the day.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Histologically proven stage IIIa, IIIb primary colon cancer (not including RS) (Japanese Classification of Colorectal cancer 7th Ehition).
2.R0, R1.
3.No prior cancer treatment (radiationtherapy, chemotherapy, immunotherapy) before surgery.
4.Age between 20 and 80 years.
5.Performance status of 0-1.
6.Restriction about combined medicine, combination therapy: Chemotherapeutic agent, immunotherapeutic agent or radiation therapy that may effect on this study's result is not combined in principle, except for metastasis or relapse.
7.Organ functions (clinical test value): within 2 weeks before enrollment.
White blood cell count: >= 4,000/mm3 and <12,000/mm3
Neutrophil count (ANC): >= 2,000/mm3
Blood platelet count: >= 90,000 /mm3
Hemoglobin: >= 9.0g/dl
Serum GOT and GPT: <100IU/L
Serum total bilirubin: <2.0mg/dl Serum creatinine: <= 1.5mg/dL
8.Written informed consent.

Key exclusion criteria

1.Synchronous or metachronous colorectal cancer.
2.History of hypersensitivity for capecitabine drug product component or fluorouracil.
3.Patients who need continuing use of warfarin potassium and phenytoin.
4.History of serious drug allergy (>= grade 3).
5.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure).
6.Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period
7.No birth-control.
8.HIV positive.
9.Not suitable for participating in the study for any other reason.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Izumi TAKEYOSHI

Organization

Gunma University Graduate School of Medicine

Division name

Department of Thoracic and Visceral Organ Surgery

Zip code


Address

3-39-15 Showa-Machi, Maebashi, Gunma, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Osamu TOTSUKA

Organization

Gunma University Graduate School of Medicine

Division name

Department of Thoracic and Visceral Organ Surgery

Zip code


Address

3-39-15 Showa-Machi, Maebashi, Gunma, JAPAN

TEL

027-220-7111

Homepage URL


Email



Sponsor or person

Institute

Gunma University Graduate School of Medicine
Department of Thoracic and Visceral Organ Surgery

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

群馬大学医学部附属病院(群馬県)他


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 14 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

No longer recruiting

Date of protocol fixation

2008 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2008 Year 03 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

2011 Year 10 Month 14 Day

Last modified on

2011 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name