UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010985
Receipt number R000012842
Scientific Title Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer
Date of disclosure of the study information 2013/06/19
Last modified on 2017/05/25 12:28:24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer

Acronym

Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer:QUACK trial

Scientific Title

Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer

Scientific Title:Acronym

Examination of relationship between quality of life and adverse events in the first -line treatment including cetuximab for KRAS wild-type unresectable colorectal cancer:QUACK trial

Region

Japan


Condition

Condition

unresectable colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the correlation between adverse event and QoL in the first line cetuximab containing regimen for unresectable colorectal cancer patients

Basic objectives2

Others

Basic objectives -Others

quality of life (QoL)

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. correlation between skin toxicity +/- other adverse events and QoL
2. correlation between efficacy and skin toxicity
3. correlation between efficacy and QoL
4. concordance between DLQI and EORTC QLQ-C30

Key secondary outcomes



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

Diagnosis

Type of intervention

Other

Interventions/Control_1

QoL assessment for the patient treated with 1st line cetuximab containing 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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients(pts) with advanced colorectal cancer (CRC) planned to be treated with a cetuximab containing regimen
2. EGFR positive CRC
3. Not decided KRAS mutated within codon 12 or 13 CRC
4. Pts with evaluable disease
5. No prior chemotherapy for advanced CRC
6. ECOG PS 0 to 2
7. Preserved organ function
8. Life expectancy of more than 3 months
9. HBsAg negative
10. Agreement of contraception
11. Written informed consent
12. Ability to answer to the QoL questionnaires

Key exclusion criteria

1. Serious bone marrow suppression
2. Serious sensory disturbance
3. History of mental disturbance of cerebrovascular attack
4. Irradiation for evaluable disease
5. Severe stenosis of primary site
6. Serious drug hypersensitivity or a history of allergic reaction from drugs
7. Uncontrolled hypertension, diabetes, or hypercalcemia
8. Liver cirrhosis, hepatic failure or renal failure
9. Interstitial lung disease, pulmonary fibrosis or pulmonary emphysema.
10. Active infection
11. Heart insufficiency or history of heart insufficiency
12. Brain metastases
13. Massive pleural effusion, ascites or pericardial effusion.
14. Watery diarrhea
15. Active concomitant malignancy
16. Pregnant woman, possibility pregnant woman, or nursing woman
17. Patients considered ineligible for the trial

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kensei Yamaguchi

Organization

Saitama Cancer Center

Division name

Department of Gastroenterology

Zip code


Address

Komuro 818 Ina-machi Kita Adachi-gun Saitama 362-0806 Japan

TEL

048-722-1111

Email

k-yamaguchi@cancer-c.pref.saitama.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Ooki

Organization

Saitama Cancer Center

Division name

Department of Gastroenterology

Zip code


Address

Komuro 818 Ina-machi Kita Adachi-gun Saitama 362-0806 Japan

TEL

048-722-1111

Homepage URL


Email

sp9y9tq9@piano.ocn.ne.jp


Sponsor or person

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name



Funding Source

Organization

Merck Serono Co., Ltd.
Bristol-Myers K.K.

Organization

Division

Category of Funding Organization

Profit organization

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

恵佑会札幌病院(北海道)、東海中央病院(岐阜県)、埼玉県立がんセンター(埼玉県)、松田病院(静岡県)岡本病院(兵庫県)、岐阜県立多治見病院(岐阜県)、京都民医連中央病院(京都府)、神戸市立医療センター中央市民病院(兵庫県)、 福井県済生会病院(福井県)、山形県立中央病院(山形県)、りんくう総合医療センター(大阪府)、金沢社会保険病院(石川県)、神戸医療センター(兵庫県)、関西労災病院(兵庫県)、岡山労災病院(岡山県)、京都逓信病院(京都府)、松山赤十字病院(愛媛県)、岐阜赤十字病院(岐阜県)、国立病院機構名古屋医療センター(愛知県)、佐野病院(兵庫県)、西宮市立中央病院(兵庫県)、県立広島病院(広島県)、東大阪市立総合病院(大阪府)、大垣市民病院(岐阜県)、岐阜市民病院(岐阜県)、大手前病院(大阪府)、済生会滋賀県病院(滋賀県)、群馬県立がんセンター(群馬県)、高知大学(高知県)、住友別子病院(愛媛県)、岐阜大学医学部(岐阜県)、独立行政法人地域医療機能推進機構 星ヶ丘医療センター (大阪府)、相澤病院(長野県)、大阪労災病院(大阪府)、四国中央病院(愛媛県四)、公立甲賀病院(滋賀県)、帝京大学医学部付属病院(東京都)、金沢医科大学(石川県)、松下記念病院(大阪府)、町田市民病院(東京都)、京都府立医科大学(京都府)、八尾市立病院(大阪府)、千葉県がんセンター(千葉県)、横浜市立市民病院(神奈川県)、市立堺病院(大阪府),大阪府済生会千里病院(大阪府)、公立学校共済組合 近畿中央病院(兵庫県)、川崎病院(兵庫県)、中濃厚生病院(岐阜県)、岡山赤十字病院(岡山県)、関西医科大学附属枚方病院(大阪府)、市立貝塚病院(大阪府)、多摩総合医療センター(東京都)、菊川市立総合病院(静岡県)、神奈川県立がんセンター(神奈川県)、兵庫医科大学病院(兵庫県)、製鉄記念広畑病院(兵庫県)、岡山医療センター(岡山県)、枚方公済病院(大阪府)、厚生連高岡病院(富山県)、京都市立病院(京都府)、第二岡本総合病院(京都府)、石川県立中央病院(石川県)、昭和大学横浜市北部病院(神奈川県)、日本赤十字社医療センター(東京都)、立川綜合病院(新潟県)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 19 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

2013 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 19 Day

Last follow-up date

2016 Year 04 Month 20 Day

Date of closure to data entry

2016 Year 11 Month 07 Day

Date trial data considered complete

2016 Year 11 Month 28 Day

Date analysis concluded

2016 Year 11 Month 28 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 17 Day

Last modified on

2017 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012842


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name