UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020784
Receipt No. R000023991
Scientific Title Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
Date of disclosure of the study information 2016/01/29
Last modified on 2020/06/19

* 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 Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
Acronym QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
Scientific Title Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
Scientific Title:Acronym QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
Region
Japan

Condition
Condition urothelial cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present prospective study was to compare the quality of life, safety and efficacy of gemcitabine/cisplatin or gemcitabine/carboplatin therapy in patients with advanced urothelial cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.
Key secondary outcomes Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients must have histologic proof of urothelial cancer.
Patients with primary tumors arising in the upper urinary tract (ureter or renal pelvis), bladder or urethra are eligible
Patients must have an evaluation in the department of urology.
ECOG performance status (PS) of 0, 1 or 2 if of recent onset and due entirely to the cancer and not due to comorbidity (especially if the compromised performance status is related to uncontrolled pain which is expected to be rapidly reversible when therapy starts)
Normal liver function (Transaminase (AST or ALT) </= 3 * the ULN, Conjugated bilirubin </= 1.5 mg/dl (or total bilirubin </= 2.5 mg/dl)
No severe chronic heart failure
Not severe renal dysfunction (eGFR < 30 ml/min/1.72m2)
Patients with other malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response in the cystectomy specimen. The expected survival from the prior malignancy should reliably be > 4 years to be eligible for this study.
Patients must be >/= 20 years of age.
Key exclusion criteria Patients must not have current, recent (within 3 weeks), or planned participation with other experimental medication clinical trials.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction or unstable angina within 6 months prior to study enrollment.
History of stroke or transient ischemic attack within 6 months prior to study enrollment.
Clinically significant peripheral vascular disease (e.g., aortic aneurysm, aortic dissection).
Symptomatic peripheral vascular disease.
Evidence of bleeding diathesis or coagulopathy.
Known history of central nervous system or brain metastases.
Lactating women.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to therapy. Patients with Crohn's disease will be excluded.
Serious, non-healing wound, ulcer, or bone fracture.
Other malignancies with severe prognosis (overall survival expected within 1 year)
Inability to comply with study and/or follow-up procedures, or sign informed consent.
Patients who are not candidates, or are unwilling to undergo systemic chemotherapy.
Patients with fluid collections (such as ascites, or pleural effusions) are not eligible for therapy.
Know hypersensitivity to any component of gemcitabine, cisplatin, or carboplatin
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code 036-8562
Address Hirosaki
TEL 0172395091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name Itsuto
Middle name
Last name Hamano
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code 0368562
Address Hirosaki
TEL 0172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Oyokyo Kidney Research Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dept. of Urology, Hirosaki University Graduate School of Medicine
Address Hirosaki
Tel +81172395091
Email shingorilla2@gmail.com

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
2016 Year 01 Month 29 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
2013 Year 04 Month 01 Day
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
Design: Cohort study
Recruitment period: June 2013 to June 2018, at Hirosaki University Hospital, who met the inclusion criteria.
We compared quality of life (QOL) using QLQ-C30 questionnaire at day 1, 3, and 15 in each cycle. Primary endpoint is the QOL differences between before and after 2 courses of neoadjuvant chemotherapy. Secondary endpoints included tumor response (RECIST v1.1), rate of weight loss, renal faction decline, toxicity and safety, and changes of anti-tumor immune cells (NK cell or T cells).

Management information
Registered date
2016 Year 01 Month 28 Day
Last modified on
2020 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023991

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.