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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013198
Receipt No. R000015390
Scientific Title Phase II study of preoperative chemotherapy using FOLFOX for obstructive colon cancer
Date of disclosure of the study information 2014/02/19
Last modified on 2020/10/16

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Basic information
Public title Phase II study of preoperative chemotherapy using FOLFOX for obstructive colon cancer
Acronym PROBE study
Scientific Title Phase II study of preoperative chemotherapy using FOLFOX for obstructive colon cancer
Scientific Title:Acronym PROBE study
Region
Japan

Condition
Condition obstructive colon cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The subject of this study is to clarify the feasibility and safety of the neoadjuvant FOLFOX for obstructive colon cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse event rate, surgical complication rate, R0 resection rate, CR rate, completion rate, relapse free survivalrate, overall survival rate

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 1. diverting stoma
patients undego making divering stoma for the purpose of the intestinal decomplession.
2. neoadjuvant chemotherapy
(6 courses of FOLFOX)
It stats within 4 weeks after making diverint stoma using mFOLFOX6 regimen (85mg/m2 of L-OHP, 400mg/m2 of bolus 5-FU and 2400mg/m2 of 48h continuous 5-FU).
3. resection of the primary lesion
Surgical treatment perform within 8 weeks after neoadjuvant FOLFOX.
4. adjuvant chemotherapy
(6 corses of FOLFOX)
It stats within 8 weeks after the surgical operation using mFOLFOX6 regimen.
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. Diagnosis of obstructive colon adenocarcinoma
2.
1) clinical stage II, III
2) tumor location is from cecum to rectosigmoid.
3) Fillful at least one or more criteria of intestinal obstruction following,
i) unable to eat
ii) no flatus
iii) existance of abdominal distension
iV) neveau in abdominal X-ray
4) aged between 20 and 80 years old
5) ECOG Performance status of 0 or 1
6) more than three months of expected survival time
7)at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0
8) no prior chemotherapy or radiotherapy
9) adequate bone marrow function with absolute neutrophil count >1,500/microl, platelet count >100,000/microl, adequate liver function with total bilirubin<=2 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=5 x ULN, adequate renal function with serum creatinine <=2 x ULN
10) willing to provide written informed consent.
Key exclusion criteria 1)history of severe drug hypersensitivity
2)history of having severe paresis or dysesthesia
3)history of another malignancy within 5 years
4)Active infections
5)Severe concurrent disease such as poorly controlled hypertension,poorly controlled diabetes,interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure.
6)serum HBs antigen positive
7)Ascites or pleural effusion requiring treatment
8)fresh intestinal bleeding
9)intestinal perforation or penetration
10)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy
11)Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama City University Hospital
Division name gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Ota/ Atsushi Ishibe
Organization Yokohama City University Medical Center
Division name Gastroenerological Center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email m_ota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横須賀共済病院(神奈川県)
横浜市立市民病院(神奈川県)
藤沢市民病院(神奈川県)
済生会横浜市南部病院(神奈川県)
独立行政法人国立病院機構横浜医療センター(神奈川県)
横浜みなと赤十字病院(神奈川県)
横浜船員保険病院(神奈川県)
横須賀市立市民病院(神奈川県)
伊東市民病院(神奈川県)
NTT東日本関東病院(神奈川県)
済生会若草病院(神奈川県)
横浜掖済会病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 19 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/32941273/
Number of participants that the trial has enrolled 50
Results The objective response rate as the primary endpoint was 67.4%. Neoadjuvant chemotherapy using mFOLFOX6 was feasible and might be a treatment option for patients with obstructive colon cancer.
Results date posted
2020 Year 10 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Eligible cases of 50 cases were 46. Median age was 69 years (45-78 years old). 26 male and 20 female. Location of tumor ;cecum 3, ascending colon 11, transverse colon 6, descending colon 5, sigmoid colon 13, rectosigmoid colon 8 cases. Clinical stage; 18 cases of Stage II, 28 cases of Stage III
Participant flow 50 cases were registered. Eligible cases of 50 were 46 cases. 45 cases underwent surgery.
Adverse events One case died due to adverse event of neoadjuvant chemotherapy.
Outcome measures Primary endpoint; Objective response rate was 67.4%
Secondary endpoint; 3-year relapse-free survival was 76.5%, 3-year overall survival was 95.4%.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 11 Month 05 Day
Date of IRB
2013 Year 11 Month 28 Day
Anticipated trial start date
2014 Year 03 Month 27 Day
Last follow-up date
2019 Year 07 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
2014 Year 02 Month 19 Day
Last modified on
2020 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015390

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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