UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018624
Receipt number R000021553
Scientific Title A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.
Date of disclosure of the study information 2015/08/10
Last modified on 2018/02/15 11:21:44

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Basic information

Public title

A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.

Acronym

A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.

Scientific Title

A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.

Scientific Title:Acronym

A phase II randomized controlled trial comparing perioperative mFOLFOXIRI with perioperative chemoradiotherapy for locally advanced rectal cancer.

Region

Japan


Condition

Condition

Rectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety, Efficacy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

RFS:3 years relapse free survival

Key secondary outcomes

Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

preoperative FOLFOXIRI+surgery

Interventions/Control_2

preoperative chemoradiotherapy+surgery

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

74 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Pathologically proven adenocarcinoma.
2. Primary tumor located at Rectosigmoid, Upper rectum, Lower rectum, and Anal canal.The lower border of the tumor located between the peritoneal reflection and the anal verge.
3. cT3and cT4a tumor on contrast-enhanced CT or MRI
4. Lateral lymph nodes without 7mm and more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN0-cN2) .
5. No distant metastasis on contrast-enhanced CT or MRI (cM0)
6. Aged 20 to 74 years old
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
8. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment
1) Neutrophil count >= 1,500 /mm3
2) Platelet count >= 100,000 /mm3
3) Hemoglobin >= 9.0 g/dL
4) T.Bil =< 2.0 mg/dL
5) AST =< 100 IU/L, ALT =< 100 IU/L
6) Cr =< 1.5 mg/dL
9. Written informed consent

Key exclusion criteria

1. Currently treated with systemic steroids or immunosuppressive agent
2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma
3. Infectious disease to be treated
4. Positive for HBs antigen
5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem
6. Grade 1 or more peripheral neuropathy
7. Women during pregnancy, possible pregnancy or breast-feeding
8. Severe mental disease
9. Attending physician determines that the case was inappropriate as the subject of this study

Target sample size

34


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhisa Uchiyama

Organization

Osaka Medical College Hospital

Division name

Department of general and gastroenterological surgery

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

072-683-1221

Email

uchi@poh.osaka-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keitarou Tanaka

Organization

Osaka Medical College Hospital

Division name

Department of general and gastroenterological surgery

Zip code


Address

2-7 Daigaku-machi, Takatsuki City, Osaka, Japan

TEL

072-683-1221

Homepage URL


Email

sur036@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka Medical College Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical College Hospital

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

大阪医科大学附属病院


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 10 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

Completed

Date of protocol fixation

2015 Year 07 Month 06 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 10 Day

Last modified on

2018 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021553


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name