UMIN-CTR Clinical Trial

Public title

A feasibility study of capecitabine and oxaliplatin (XELOX)
for patients with stage II/III colon cancer.

Acronym

ACTOR study

Scientific Title

A feasibility study of capecitabine and oxaliplatin (XELOX)
for patients with stage II/III colon cancer.

Scientific Title:Acronym

ACTOR study

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate feasibility, safety and efficacy of adjuvant XELOX in patients with stage II/III colon cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Completion rate of treatment

Key secondary outcomes

1 Completion rate of L-OHP
2 Disease-free survival
3 Recurrent-free survival
4 Overall survival
5 Adverse effect
6 Correlation of relative dose intensity with prognosis
7 Correlation of stage with prognosis

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

XELOX
Capecitabine:2000mg/m2 d1-14
Oxaliplatin:130mg/m2 d1
Q3w

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Histological confirmation of stage II/III colorectal cancer.
2. Prior surgical resection with D2 or greater lymphadenectomy.
3. Surgical diagnosis as Cur A.
4. Adjuvant chemotherapy is planned within 8 weeks after surgery.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
6. No history of prior chemotherapy or radiation.
7. Age of 20 years or older.
8. Capable of oral intake.
9. Vital organ functions (listed below) are preserved within 2 weeks prior to entry
i. WBC4000/mm3 or greater (12,000/mm3 or lesser)
ii. Neurtophils: 2000/mm3 or greater
iii. Platelets: 100,000/mm3 or greater
iv. Hemoglobin: 9.0g/dl or greater
v. AST and ALT: upper limit of normal (ULN)*2.5 or lesser.
vi. Total bilirubin: upper limit of normal (ULN)*2 or lesser.
vi. Serum creatinine: upper limit of normal (ULN)*1.25 or lesser.
10. Written informed consent

Key exclusion criteria

1. Severe peripheral sensory neuropathy
2. History of the serious hypersensitivity for drugs.
3. Active infection.
4. Complications (Evidence of interstinal lung disease, or pulmonary fibrosis, paralytic or mechanical bowel obstruction, uncontrolled hypertension, uncontrolled diabetes mellitus, cirrhosis, active cardiovascular disease, or past or current history (within 3 months) of myocardial infarction.
5. Multiple primary cancer within 5years.
6. Uncontrolled diarrhea.
7. Clinically significant mental or psychological disease.
8. Pregnancy, lactation period.
9. Other conditions not suitable for this study

Target sample size

36

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Mizunuma

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology

Zip code

Address

135-8550, 3-8-31 Ariake Koto-ku Tokyo

TEL

+81-3-3520-0111

Email

mizunuma@jfcr.or.jp

Name of contact person

1st name
Middle name
Last name	Mitsukuni Suenaga

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology

Zip code

Address

135-8550, 3-8-31 Ariake Koto-ku Tokyo

TEL

+81-3-3520-0111

Homepage URL

Email

m.suenaga@jfcr.or.jp

Institute

Japanese Foundation for Cancer Research

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

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

公益財団法人がん研究会有明病院

Date of disclosure of the study information

2012

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2012

Year

05

Month

16

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

2017

Year

05

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

05

Month

26

Day

Last modified on

2018

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009455