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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022924
Receipt No. R000024975
Scientific Title Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Date of disclosure of the study information 2016/07/01
Last modified on 2018/07/01

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Basic information
Public title Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Acronym Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Scientific Title Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Scientific Title:Acronym Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
Region
Japan

Condition
Condition colorectal cancer with peritoneal metastasis
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the safety of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety
Key secondary outcomes One year survival rate, progression free survival, response rate, the rate of improvement of peritoneal cancer index, the rate of negative conversion of the cytology of peritoneal lavage

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 20mg/m2 of weekly Intraperitoneal paclitaxel
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) The cases of primary or recurrent colorectal cancer which are histologically confirmed as adenocarcinoma. (The cases of appendiceal carcinoma and anal canal cancer are excluded.)
2) Peritoneal carcinomatosis is detected or suspected.
3) The cases without uncontrollable distant metastases.
4) The cases within 2 months from the beginning of surgery or chemotherapy for peritoneal carcinomatosis.
5) The cases which meet criteria as follows:
1. The number of white blood cells:
More than lower limit of standard value and less than 12,000/mm3
2. The number of neutrophil:
More than 1,500/mm3
3. The amount of hemoglobin:
More than 8.0 g/dl
4. The number of platelet:
More than 100,000/mm3
5. AST/ALT:
Less than 100 U/L
6. Total bilirubin:
Less than 1.5 times as much as upper limit of standard value.
7. eGFR:
More than eGFR: 60 mL/min/1.73m2
6) Performance Status (ECOG scale): 0-1
7) Informed consent is obtained.
Key exclusion criteria 1) The patients who have another cancer in the time of entry.
2) The patients who have large amount of ascites which requires drainage more than three times per week.
3) Postoperative chemotherapy including oxaliplatin was performed within 1 year.
4) The cases with contraindication of fluorouracil, levofolinate calcium, capecitabine, oxaliplatin, bevacizumab, or paclitaxel.
5) The patients with brain tumors or brain metastases.
6) The patients with infectious diseases.
7) The patients with thrombotic diseases or embolic diseases within one year.
8) The patients requiring anticoagulant drug.
9) PT-INR>1.5 or tendency to bleed.
10) The patients who are pregnant.
11) Attending doctor decided the patients are unsuitable for this study.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nozawa
Organization The University of Tokyo
Division name Department of Surgical Oncology and Vascular Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email nozawah-sur@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Murono
Organization The University of Tokyo
Division name Department of Surgical Oncology and Vascular Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email MURONOK-SUR@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 28 Day
Last modified on
2018 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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