UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002602
Receipt number R000003033
Scientific Title Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Date of disclosure of the study information 2009/10/09
Last modified on 2010/08/10 21:49:53

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Basic information

Public title

Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer

Acronym

Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer

Scientific Title

Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer

Scientific Title:Acronym

Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer

Region

Japan


Condition

Condition

Rectal cancer

Classification by specialty

Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to establish the feasibility and efficacy of preoperative radiotherapy (RT) with TS-1, CPT-11 and cetuximab in patients with locally advanced rectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Dose-limiting toxicities (DLTs)
Complication rate
R0 resection rate
downstaging 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

S-1:80mg/m2 day1-14, 22-35
CPT-11:Level 1 100mg/m2, Level 2 125mg/m2, Level 3 150mg/m2 day1, 22
Cetuximab:400mg/m2 day-7, 250mg/m2 day1, 8, 15, 22, 29, 36
Radiation:1.8 Gy of consecutive 5 days, total dose 50.4 Gy

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

T3-T4 low rectal cancer
Wild type K-ras was observed in DNA analysis.

Key exclusion criteria

Patients were excluded if they had prior RT to the pelvic region or previous cytotoxic chemotherapy or if they had other synchronous cancers. Patients suffering from the following conditions were also ineligible: inflammatory bowel disease, malabsorption syndrome, ischemic heart disease, peripheral neuropathy, and psychiatric disorders or psychologic disabilities thought to adversely affect treatment compliance. In addition, pregnant or lactating patients and women with childbearing potential who lacked effective contraception were excluded.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuyoshi Ota

Organization

Yokohama City University Graduate School of Medicine

Division name

Gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan

TEL

045-787-2650

Email



Public contact

Name of contact person

1st name
Middle name
Last name Mitsuyoshi Ota

Organization

Yokohama City University Graduate School of Medicine

Division name

Gastroenterological surgery

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan

TEL

045-787-2650

Homepage URL


Email

m_ota@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



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

2009 Year 10 Month 09 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

Open public recruiting

Date of protocol fixation

2009 Year 08 Month 21 Day

Date of IRB


Anticipated trial start date

2009 Year 09 Month 01 Day

Last follow-up date

2014 Year 08 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

2009 Year 10 Month 08 Day

Last modified on

2010 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name