Unique ID issued by UMIN | UMIN000004361 |
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Receipt number | 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 15:56:28 |
Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)
Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)
Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)
Pilot study of early start of chemotherapy after excision of the primary colorectal cancer. (Pearl star 01)
Japan |
Colorectal Cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the early start of chemotherapy after excision of the primary colorectal cancer.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Safety
Response rate
Time to treatment failure
Overall survival
Progression free survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
5
1st name | Yoichiro |
Middle name | |
Last name | Yoshida |
Fukuoka University School of Medicine
Department of Gastroenterological Surgery
8140180
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
0928011011
yy4160@yahoo.co.jp
1st name | Yoichiro |
Middle name | |
Last name | Yoshida |
Fukuoka University School of Medicine
Department of Gastroenterological Surgery
8140180
7-45-1,Nanakuma,Johnan-ku,Fukuoka ,814-0180,Japan
0928011011
yy4160@yahoo.co.jp
Department of Gastroenterological Surgery
Fukuoka University School of Medicine
None
Self funding
Fukuoka Univesity
7-45-1 Nanakuma, Jonan-ju
0928011011
yy4160@yahoo.co.jp
NO
福岡大学医学部消化器外科学
2010 | Year | 10 | Month | 10 | Day |
https://www.ncbi.nlm.nih.gov/pubmed/23388092
Published
https://www.ncbi.nlm.nih.gov/pubmed/23388092
5
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.
2019 | Year | 05 | Month | 23 | Day |
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.
This pilot study completed its accrual goal of five patients between December 2010 and April 2011. The minimum follow-up period was 12 months.
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.
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.
Completed
2010 | Year | 08 | Month | 09 | Day |
2010 | Year | 09 | Month | 15 | Day |
2010 | Year | 10 | Month | 01 | Day |
2016 | Year | 12 | Month | 31 | Day |
2010 | Year | 10 | Month | 08 | Day |
2019 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005205
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