UMIN-CTR Clinical Trial

Public title

Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)

Acronym

Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)

Scientific Title

Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)

Scientific Title:Acronym

Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the early start of chemotherapy after excision of the primary colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Safety

Key secondary outcomes

Response rate
Time to treatment failure
Overall survival
Progression free survival

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

Oxaliplatin 130mg/m2 i.v. (day1)
Bevaciumab 7.5mg/Kg i.v. (day1)
Capecitabine2,000mg/m2 p.o.(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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Histologically confirmed colorectal cancer
2.Unresectable synchronous liver metastases
3.Resection of primary colorectal cancer
4.No prior chemotherapy and radiotherapy for colorectal cancer
5.Performance Status: 0-1 (ECOG criteria)
6.Age: 20 years to 75 years
7.Vital organ functions are preserved within 7 days prior to entry
WBC : >= 3,000 and =< 12,000/mm3
Neutrophil : >=1,500/mm3
Platelet : >= 100,000/mm3
T.bil.: <= 1.5 mg/dl
AST,ALT : 2.5 times of normal range in each institute
Creatinin : <= upper limit of each institute
8.Signed written informed consent

Key exclusion criteria

1.Prior severe drug allergy
2.Cavity fluid which needs drainage
3.Presence of active infection
4.Symptomatic brain metastases
5.Multiple malignancy within 5 years disease free interval
6.Uncontrolled hypertension
7.Uncontrolled diabetes
8.Peripheral nerve disorder
9.Severe pulmonary disease
10.Significant electrocardiographic abnormality
11.Treatment with anti-platelet drug
12.Chronic systemic treatment of corticosteroid
13.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy
14.Inadequate for study enrollment by the physician

Target sample size

5

Name of lead principal investigator

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

8140180

Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL

0928011011

Email

yy4160@yahoo.co.jp

Name of contact person

1st name	Yoichiro
Middle name
Last name	Yoshida

Organization

Fukuoka University School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

8140180

Address

7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan

TEL

0928011011

Homepage URL

Email

yy4160@yahoo.co.jp

Institute

Department of Gastroenterological Surgery
Fukuoka 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

Fukuoka Univesity

Address

7-45-1 Nanakuma, Jonan-ju

Tel

0928011011

Email

yy4160@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福岡大学医学部消化器外科学

Date of disclosure of the study information

2010

Year

10

Month

10

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/23388092

Publication of results

Published

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/23388092

Number of participants that the trial has enrolled

5

Results

Five patients underwent open surgery. The procedures included right hemicolectomy in 1 patient, sigmoidectomy in 2 patients, high anterior resection in 1 patient, and Hartmann procedure in 1 patient. All patients started chemotherapy on postoperative day 7. The median number of cycles of chemotherapy was 11 (8 to 22). No postoperative complications were observed. The tumor reduction rate was 44.3% (32.0 to 66.6%). Progression-free survival was 10.3 months.

Results date posted

2019

Year

05

Month

23

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

There were five men male patients with a median age of 67 years (range 50 to 72 years). All patients had tumors that were almost completely obstructive, with stenosis preventing the passage of the endoscope. Five patients underwent open surgery. A right hemicolectomy was performed in one patient, sigmoidectomy in two patients, a high anterior resection without a protective stoma in one patient, and a Hartmann procedure was performed in one patient. The median operating time was 130 minutes (range 75 to 225 minutes), and estimated blood loss was 60 mL (range 15 to 229 mL). The two patients who underwent sigmoidectomy had the longest operating times because of a history of previous surgery.

Participant flow

This pilot study completed its accrual goal of five patients between December 2010 and April 2011. The minimum follow-up period was 12 months.

Adverse events

wo patients had grade 2 thrombocytopenia. Grade 1 hand-foot syndrome was observed in all patients. Grade 3 anorexia was observed in one patient. All adverse events were identified after the first seven postoperative days. No patient experienced other grade 3 or greater toxicities (Table 3). No patient experienced grade 2 or greater surgical complications or the chemotherapy toxicities in the first 60 days after colorectal surgery.

Outcome measures

The primary endpoint was postoperative morbidity within 30 postoperative days, and the secondary endpoints were response rate and progression-free survival (PFS). The following postoperative complications were predefined and prospectively measured: abdominal infection, anastomosis leakage, abdominal bleeding, and infection of the ileus or the wound.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

08

Month

09

Day

Date of IRB

2010

Year

09

Month

15

Day

Anticipated trial start date

2010

Year

10

Month

01

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

10

Month

08

Day

Last modified on

2019

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005205