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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Colorectal Cancer | |
Classification by specialty |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 5 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yy4160@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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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 | ||||||
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 | |
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Research case data | |
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