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 |
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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
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
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
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
