UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020784
Receipt number 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 2022/12/05 22:13:02

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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 or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



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

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

83

Results

QOL analyses were performed in 39 patients receiving GCis and in 44 patients receiving GCb. Appetite loss, role functioning, nausea/vomiting, physical, and fatigue deteriorated >10% from baseline in the GCis group but not in the GCb group. Constipation worsened, whereas scores for pain and emotional items improved in both groups. Objective response rates were 38.5 and 43.2% in the GCis and GCb groups, respectively.

Results date posted

2022 Year 12 Month 05 Day

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

2013 Year 04 Month 01 Day

Date of IRB

2021 Year 04 Month 30 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

2022 Year 12 Month 05 Day



Link to view the page

Value
https://center6.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