Unique ID issued by UMIN | UMIN000020784 |
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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 |
Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)
QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
Japan |
urothelial cancer
Urology |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.
Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.
Observational
20 | years-old | <= |
90 | years-old | >= |
Male and Female
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.
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
200
1st name | Shingo |
Middle name | |
Last name | Hatakeyama |
Hirosaki University Graduate School of Medicine
Urology
036-8562
Hirosaki
0172395091
shingorilla2@gmail.com
1st name | Itsuto |
Middle name | |
Last name | Hamano |
Hirosaki University Graduate School of Medicine
Urology
0368562
Hirosaki
0172395091
shingorilla2@gmail.com
Hirosaki University Graduate School of Medicine
Oyokyo Kidney Research Institute
Other
JAPAN
Dept. of Urology, Hirosaki University Graduate School of Medicine
Hirosaki
+81172395091
shingorilla2@gmail.com
NO
2016 | Year | 01 | Month | 29 | Day |
Published
83
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.
2022 | Year | 12 | Month | 05 | Day |
Completed
2013 | Year | 04 | Month | 01 | Day |
2021 | Year | 04 | Month | 30 | Day |
2013 | Year | 06 | Month | 01 | Day |
2025 | Year | 03 | Month | 31 | Day |
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).
2016 | Year | 01 | Month | 28 | Day |
2022 | Year | 12 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023991
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