UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004361
Receipt No. R000005205
Scientific Title Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)
Date of disclosure of the study information 2010/10/10
Last modified on 2019/05/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition Colorectal Cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes Safety
Key secondary outcomes Response rate
Time to treatment failure
Overall survival
Progression free 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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Gastroenterological Surgery
Fukuoka University School of Medicine
Institute
Department

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 Fukuoka Univesity
Address 7-45-1 Nanakuma, Jonan-ju
Tel 0928011011
Email yy4160@yahoo.co.jp

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 福岡大学医学部消化器外科学

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 10 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pubmed/23388092
Publication of results Published

Result
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

Progress
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
Other related information

Management information
Registered date
2010 Year 10 Month 08 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.