UMIN-CTR Clinical Trial

Public title

Pilot study of FOLFOX or XELOX Therapy Versus FOLFOX or XELOX + PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colon Cancer

Acronym

Pilot study of FOLFOX or XELOX + PSK Therapy as Postoperative Adjuvant Therapy for Stage III Colon Cancer

Scientific Title

Pilot study of FOLFOX or XELOX Therapy Versus FOLFOX or XELOX + PSK Therapy as Postoperative Adjuvant Therapy for Histological Stage IIIa and IIIb Colon Cancer

Scientific Title:Acronym

Pilot study of FOLFOX or XELOX + PSK Therapy as Postoperative Adjuvant Therapy for Stage III Colon Cancer

Region

Japan

Condition

Colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to compare the compliance and adverse events of mFOLFOX6(or XELOX) and mFOLFOX6(or XELOX) + PSK therapies for patients with histological stage IIIa/IIIb colon cancer who have undergone curative surgery.
The endpoints are the percentage of patients who complete scheduled treatment, adeverse events, and the extent of changes of IL-12 and the number of NK cells in peripheral blood during treatment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

The percentage of patients who complete scheduled treatment

Key secondary outcomes

Adverse events, IL-12 and the number of NK cell in peripheral blood,

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients are registered and assigned within 6weeks after surgery.
Group A : mFOLFOX6
Levofolinate and L-OHP are given intravenously for 2 hours. Then, 5-FU is given as a continuous intravenous infusion for 46 hours after infusion (or injection) of 5-FU. 1 course takes 2 weeks. Treatment is repeated 12 courses (for 24 weeks).
Group A' : XELOX
Oxaliplatin(L-OHP) is given intravenously for 2 hours on D1 every 21 days and Capecitabine is taken on D1-14 every 21 days. 1 course takes 3 weeks. Treatment is repeated 8 courses (for 24 weeks).

Interventions/Control_2

Group B: mFOLFOX6(or XELOX)/Krestin
mFOLFOX6(or XELOX) therapy is the same as group A(group A').
Krestin is given orally at a fixed dose of 3g/day in three divided doses (morning, daytime, evening) for 24 weeks from the start of mFOLFOX6(or XELOX) treatment.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patient with histological stage IIIa or IIIb cancer with primary Colon adenocarcinoma (including RS)
2. Patient who has undergone curative surgery with no residual cancer
3. Pretreatment criterion: patient who has not undergone preoperative cancer treatment (radiotherapy, chemotherapy or immunotherapy)
4. Patient who is at least 20 years and below 80 years of age, and who is judged to be capable of observation for three years.
5. Patient with performance status (PS) of 0-1 (according to Eastern Cooperative Oncology Group, ECOG)
6. Organ function (laboratory data): patient who satisfies the following conditions or data of laboratory tests conducted within 2 weeks prior to start of trial
a)White blood cell count: >=4,000/mm3 and <12,000/mm3
b)absolute neutrophil count: >=2000/mm3
c)Platelet count: >=100,000/mm3
d)Hb: >=9.0g/dl
e)Serum total bilirubin: < 1.5 mg/dL
f)Serum AST and ALT: < 100 IU/L
g)Serum creatinine: <=1.1 mg/dL(Male) <=0.7mg/dL(Female) and eCCr >=50 mL/min
h)Normal ECG
7. Patient with capable of oral intake
8. Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study

Key exclusion criteria

1. Patient with metachronous or synchronous cancer
2. Patient who requires continuous use of phenytoin or warfarin potassium
3. Patient who has experienced serious drug allergy over grade 3 in the past
4. Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency
5. Patient who is pregnant or in lactation, or wish to become pregnant during this study
6. Male patient who intends to make someone pregnant during this study
7. Patient with HIV positive
8. Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Sotaro Sadahiro

Organization

Tokai University School of Medicine

Division name

Department of Surgery

Zip code

Address

143, Shimokasuya, Isehara, Kanagawa 259-1193, Japan

TEL

0463-93-1121(2294.2290)

Email

Name of contact person

1st name
Middle name
Last name	Sotaro Sadahiro

Organization

Tokai University School of Medicine

Division name

Department of Surgery

Zip code

Address

143, Shimokasuya, Isehara, Kanagawa 259-1193, Japan

TEL

0463-93-1121(2294.2290)

Homepage URL

Email

sadahiro@is.icc.u-tokai.ac.jp

Institute

Tokai University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2011

Year

03

Month

30

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

2012

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

08

Month

09

Day

Last modified on

2014

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007255