UMIN-CTR Clinical Trial

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

obstructive colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University Medical Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

02

Month

19

Day

URL releasing protocol

none

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

02

Month

19

Day

Last modified on

2020

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015390