Four Cycles Versus Six Cycles of Cisplatin-based Chemotherapy in Metastatic Urothelial Carcinoma (FOCUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03296306|
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Ureter Cancer Urethral Cancer Transitional Cell Carcinoma||Drug: Treatment duration of cisplatin based chemotherapy||Phase 3|
Urothelial carcinoma is the fifth most common cancer in men and seventh among women all around the world. Although a complete surgical resection with or without perioperative treatment is the most effective way to offer a potentially curative therapy to patients with these cancers, 25% of the patients initially present with locally or systemically advanced disease. Systemic chemotherapy is the only current modality that provides the potential for a long-term survival in patients with advanced or metastatic urothelial disease.
Cisplatin based combination chemotherapies such as GP, GP-S, MVAC, and dose dense MVAC with G-CSF supports are regarded as a backbone treatment for patients with advanced bladder cancer on the basis of the results from previous studies.
However, there is no consensus on appropriate number of chemotherapy cycles. In phase III trial comparing MVAC with GP, patients were treated with 6 cycles (every 4 weeks) of chemotherapy. In another phase III trial comparing MVAC with HD-MVAC, there is no pre-determined number of cycles, but the median number of cycles were 4 for MVAC and 6 for HD-MVAC.
However, it is hard to complete six or more cycles of cisplatin based chemotherapy due to cumulative toxicities of cisplatin such as neuropathy and development of resistance. The median age of patients with urothelial cancer is 70 years old and significant proportion of the patients already showed impaired performance status (ECOG PS ≥2).
There has already been reported in several trials of NSCLC, which showed that 4 cycles of chemotherapy containing cisplatin has no significant differences in survival or QoL with lower incidences of toxicities compared with 6 cycles of chemotherapy.
The objective of this trial is to assess whether there is any difference in OS between patients who are treated with four cycles of cisplatin based chemotherapy and patients who are treated with 6 cycles of chemotherapy to determine the optimal duration of chemotherapy in patients with advanced urothelial cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Four Cycles of Cisplatin-Based Chemotherapy in Metastatic Urothelial Carcinoma Compared to Six Cycles: Randomized Phase III Trial - FOCUS Study -|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||February 2022|
Active Comparator: 6 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)
Drug: Treatment duration of cisplatin based chemotherapy
Experimental: 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 zero to two cycles of chemotherapy (totally four cycles)
Drug: Treatment duration of cisplatin based chemotherapy
- Overall survival [ Time Frame: 5 years ]Overall survival is defined as the time from enrollment of study until death from any cause (or date of last follow-up for patients still alive)
- Progression free survival [ Time Frame: Every 6-8 weeks, from date of enrollment until the date of first documented progression ]PFS is defined as the time from enrollment of study until either first documentation of RECIST-defined disease progression or death due to any cause, whichever come first.
- Tumor response rate [ Time Frame: Every 6-8 weeks, assess the tumor response from date of enrollment ]Tumor response rate is defined as the proportion of patients with a complete response (CR) or partial response (PR) among patients with evaluable lesions for response of RECIST.
- safety using NCI Common Terminology Criteria for Adverse Events (version 4.03) [ Time Frame: Every 2-4 weeks, from date of enrollment until 30th days of last cycles treatment or initation of new regimen ]Toxicity profiles will be evaluated every cycle with physical examination, vital signs, performance status, CBC, and serum chemistry using NCI Common Terminology Criteria for Adverse Events version 4.03.
- Quality of life composite score of EORTC-QoL-C30 and EORTC CIPN20 [ Time Frame: 0-1 week, 12-18 week, 24-34 week after enrollment ]Investigators measured Quality of life using EORTC-QoL-C30 and EORTC CIPN20 at the time of enrollment, 12-18 weeks, and 30 weeks
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296306
|Contact: Jae lyun Lee, MD., PhD.||+firstname.lastname@example.org|
|Contact: MiRan Kimemail@example.com|
|Principal Investigator:||Jae-Lyun Lee, MD., PhD.||Asan Medical Center|