Prospective observational study to evaluate quality of life during chemotherapy in advanced urothelial cancer patients comparing gemcitabine/cisplatin versus gemcitabine/carboplatin(QL-GCU study)

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000020784
• Date of registration: 29/01/2016
• Prospective Registration: No
• Primary sponsor: Hirosaki University Graduate School of Medicine
• 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)
• 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) - QOL comparison between gemcitabine/cisplatin versus gemcitabine/carboplatin for the first line treatment of advanced urothelial cancer(QL-GCU study)
• Date of first enrolment: 2013/06/01
• Target sample size: 200
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023991
• Study type: Observational
• Study design: Not selected Not selected
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Itsuto Hamano
• Affiliation: Hirosaki University Graduate School of Medicine Urology

• Name: Shingo Hatakeyama
• Affiliation: Hirosaki University Graduate School of Medicine Urology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: 90years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

urothelial cancer

Primary Outcome(s)

Primary endpoint is the fatigue score changes between before and after 2 cycle of chemotherapy.

Secondary Outcome(s)

Secondary endpoints included QOL sub-score changes, tumor response (RECIST v1.1), and rates of weight loss, renal faction decline, toxicity and safety.

Source(s) of Monetary Support

Oyokyo Kidney Research Institute

Ethics review

Status: YES
Approval date: 30/04/2021
Contact:

[e-mail]

Dept. of Urology, Hirosaki University Graduate School of Medicine

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 05/12/2022
• Date Completed: 31/03/2025