Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma (FOCUS)
Bladder Cancer, Ureter Cancer, Urethral Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring urothelial carcinoma, cisplatin, first-line chemotherapy
Eligibility Criteria
Inclusion criteria:
- Patients with histologically or cytologically confirmed urothelial cancer
- Unresectable locally advanced (T3b, N2-3), metastatic (M1), or recurrent disease
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status 0-1
- Not progressed disease status after 2 or 4 cycles of platinum-based chemotherapy
- Adequate organ and bone marrow function for chemotherapy
- No history of radiation therapy, or radiation field within 25% of whole marrow would be allowed. If patients underwent radiation therapy in entire pelvis, they are excluded to this study. Patients should discontinue radiation therapy at least 4 weeks before enrollment, and the patients should be recovered from radiation therapy associated adverse events.
- Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status. Men should consent with the contraception for 6 months after the end of the study or he would be infertile.
- Patients should sign a written informed consent before study entry.
Exclusion Criteria:
- Histologic types other than urothelial cell carcinoma should be excluded. However, urothelial cell types combined with squamous or glandular features are allowed.
- Patients who showed progressed disease status after 2 or 4 cycles of platinum-based chemotherapy, cannot be treated with additional chemotherapy due to adverse events, or already undertook with reduced dose of more than 50%
- Presence or history of CNS metastasis
- Prior systemic chemotherapy (But prior intravesical chemotherapy or immunotherapy was allowed, and recurrent disease after adjuvant or neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy was administered 1 year or more before the patient enrollment)
- Peripheral sensory neuropathy grade 2 or worse according to NCI CTCAE
- History of treatment with drugs of another clinical trial within 30 days before enrollment.
- Concomitant severe medical, surgical, or psychiatric disease or problems which can affect the results of the clinical trial or have possibilities of unexpected medical problems caused be the drug of clinical trial
- History of another malignancy (but treated malignancy at least two years before enrollment were allowed, and cured non-melanoma skin cancer, any cured in-situ carcinoma, clinically insignificant localized prostate cancer, or papillary thyroid carcinoma are allowed even diagnosed less than 2 years before enrollment).
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Sites / Locations
- Kwonoh ParkRecruiting
- Hallym University Medical Center, Hallym University College of MedicineRecruiting
- Fatima HospitalRecruiting
- Keimyeong University Dongsan Medical CenterRecruiting
- Chungnam University HospitalRecruiting
- National Health Insurance Service Ilsan HospitalRecruiting
- Gil Medical CenterRecruiting
- Inje University Haeundae Paik HospitalRecruiting
- Kosin University HospitalRecruiting
- Pusan National University Hospital, Pusan National University School of MedicineRecruiting
- Asan Medical CenterRecruiting
- Chung Ang University HospitalRecruiting
- Inje University Sanggye Paik HospitalRecruiting
- Kangbuk Samsung Hospital, Sungkyunkwan University School of MedicineRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University Hospital, Cancer Research Institute, Seoul National University College of MedicineRecruiting
- VHS medical centerRecruiting
- Yonsei Cancer CenterRecruiting
- St. Vincent's Hospital, The Catholic University of KoreaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
6 cycles arm
4 cycles arm
Patients without evidence of disease progression or unacceptable toxicities after completion of two or four treatment cycles of cisplatin based chemotherapy (GP, GP-S, MVAC, HD-MVAC with GCSF) were randomly assigned to receive additional two to four cycles of chemotherapy (totally six cycles)
Patients without evidence of disease progression or unacceptable toxicities after completion of two or four treatment cycles of cisplatin based chemotherapy (GP, GP-S, MVAC, HD-MVAC with GCSF) were randomly assigned to receive additional zero to two cycles of chemotherapy (totally four cycles)