Spots Global Cancer Trial Database for Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy
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Trial Identification
Brief Title: Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy
Official Title: A Prospective Randomized Phase III Trial of Maintenance Pemetrexed Versus Observation in Patients With Recurrent or Metastatic Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy Without Disease Progression
Study ID: NCT03193788
Study Description
Brief Summary: This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.
Detailed Description: Patients with unresectable locally advanced, recurrent, or metastatic urothelial carcinoma of bladder, ureter, or renal pelvis who do not experience disease progression after 4 to 6 cycles of 1 st line chemotherapy administration. After completion of 4-6 cycles, patients without disease progression on CT which is taken within 3 weeks after administration of the last chemotherapy will be randomized within 4 weeks after administration of the last chemotherapy to assign either maintenance group or observation group. Pemetrexed 500 mg/m 2 mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle, with vitamin supplementation (folic acid 1000μg daily orally from 7 days prior to treatment initiation and vitamin B12 1000 μg IM 7 days prior to treatment initiation and then every 3 cycles). Thereafter, vitamin B12 can be injected on the same day of pemetrexed infusion. Dexamethasone 4 mg orally twice daily for 3 days beginning the day before treatment to minimize cutaneous reactions. Treatment continues until occurrence of disease progression or intolerable toxicities upto maximum of 16 cycles.
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hallym University Medical Center, Hallym University College of Medicine, Anyang, , Korea, Republic of
Keimyeong University Dongsan Medical Center, Daegu, , Korea, Republic of
Fatima Hospital, Daegu, , Korea, Republic of
Chungnam University Hospital, Daejeon, , Korea, Republic of
National Health Insurance Service Ilsan Hospital, Goyang, , Korea, Republic of
Hallym University Dongtan Sacred Heart Hospital, Hwaseong-si, , Korea, Republic of
Gil Medical Center, Incheon, , Korea, Republic of
Dong-A University Medical Center, Pusan, , Korea, Republic of
Inje University Haeundae Paik Hospital, Pusan, , Korea, Republic of
Pusan National University Hospital, Pusan National University School of Medicine, Pusan, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Chung Ang University Hospital, Seoul, , Korea, Republic of
Inje University Sanggye Paik Hospital, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, , Korea, Republic of
Yonsei Cancer Center, Seoul, , Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea, Suwon, , Korea, Republic of
Uijeongbu St Mary's hospital, Catholic university of Korea, Uijeongbu, , Korea, Republic of
Pusan National University Yangsan Hospital, Yangsan, , Korea, Republic of
Contact Details
Name: Jae-Lyun Lee, MD, PhD
Affiliation: Asan Medical Center
Role: PRINCIPAL_INVESTIGATOR
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