Bladder CancerPhase 3PREMIERNCT03193788
Pemetrexed Maintenance in Patients With Urothelial Carcinoma Who Completed First Line Platinum-based Chemotherapy
A Phase 3 study testing pemetrexed, Folic Acid and Vitamin B12 Injection in people with Bladder Cancer and Ureter Cancer, run by Asan Medical Center at 21 sites in South Korea.
Trial summary
This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bladder Cancer, Ureter Cancer, Transitional Cell Carcinoma
- What is being tested?
- pemetrexed, Folic Acid and Vitamin B12 Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 21 sitesSouth Korea
- Study dates
- Jan 2017to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmation urothelial cancer of bladder, ureter, or renal pelvis.
- Patients must present with locally advanced, recurrent or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- Patients who were administered 4-6 cycles of cisplatin-based first line chemotherapy [GP (gemcitabine/cisplatin), classic MVAC (methotrexate/vinblastine/doxorubicin/cisplatin), or dose-dense MVAC] and were planned to undergo regular surveillance
- ce after confirmation of absence of disease progression on CT taken within 3 week after the administration of the last cycle of 1st line chemotherapy.
- For patients with recurrent disease who received prior adjuvant or neoadjuvant chemotherapy with cisplatin-containing regimen, the last administration of previous treatment should be administered at least 6 months before start date of 1st line chemotherapy.
- Measurable disease according RECIST criteria v 1.1.
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- Age 20 years or older
- ECOG performance status 2 or better
- Adequate bone marrow, hepatic, and renal function
- Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
Who cannot join
- Prior systemic chemotherapy or immunotherapy for palliative aim before or after 1st line cisplatin-based chemotherapy. However, prior intravesical chemotherapy or immunotherapy is allowed.
- Disease progression during or after 1st line cisplatin-based chemotherapy
- Known CNS metastasis
- Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, early gastric carcinoma, early stage thyroid carcinoma, insignificant prostate carcinoma, or in situ carcinoma of cervix uteri
- Pregnancy or breast feeding.
- Serious hypersensitivity reaction to pemetrexed.
- Severe renal function impairment with creatinine clearance <45 mL/min by standard Cockcroft-Gault formula or GFR measured by Tc99m-DPTA serum clearance method.
- Other severe acute or chronic medical or psychiatric condition
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites, 21 recruiting
- Recruiting
Hallym University Medical Center, Hallym University College of Medicine
Anyang
Ho Young Kim, ksfam@daum.net
- Recruiting
Keimyeong University Dongsan Medical Center
Daegu, 700-712
Jin Young Kim, MD, takgu@dsmc.or.kr
- Recruiting
Fatima Hospital
Daegu
Jung Lim Lee, junglim3@gmail.com
- Recruiting
Chungnam University Hospital
Daejeon, 301-721
Hyo Jin Lee, MD, PhD., cymed@cnu.ac.kr
- Recruiting
National Health Insurance Service Ilsan Hospital
Goyang
Soo Jung Hong, suzzy901@nhimc.or.kr
- Recruiting
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si
Hyun Ae Jung, hyunaejung@hallym.or.kr
- Recruiting
Gil Medical Center
Incheon, 21565
Inkeun Park, MD, ingni79@hanmail.net
- Recruiting
Dong-A University Medical Center
Pusan
Suee Lee
- Recruiting
Inje University Haeundae Paik Hospital
Pusan
Il-Hwan Kim, onelement@daum.net
- Recruiting
Pusan National University Hospital, Pusan National University School of Medicine
Pusan
Hyo Jung Kim, leonkim80@naver.com
- Recruiting
Asan Medical Center
Seoul, 138-736
Jae-Lyun Lee, MD, PhD, 82 2 3010 5977, jaelyun@amc.seoul.kr
- Recruiting
Chung Ang University Hospital
Seoul, 156-755
Hee Joon Kim, MD, heejun.dino11@gmail.com
- Recruiting
Inje University Sanggye Paik Hospital
Seoul
Byeong Seok Sohn, imbs@paik.ac.kr
- Recruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul
Yun-Gyoo Lee, gosciny@gmail.com
- Recruiting
Korea University Anam Hospital
Seoul
Yoon Ji Choi, yoonji23@hanmail.net
- Recruiting
Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine
Seoul
Bhum Suk Keam
bhumsuk@snu.ac.kr
- Recruiting
Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea
Seoul
In-Ho Kim, ihkmd@naver.com
- Recruiting
Yonsei Cancer Center
Seoul
Sang Joon Shin, ssj338@yuhs.ac
- Recruiting
St. Vincent's Hospital, The Catholic University of Korea
Suwon
Byoung Yong Shim, shimby@catholic.ac.kr
- Recruiting
Uijeongbu St Mary's hospital, Catholic university of Korea
Uijeongbu-si
Yoon Ho Ko, koyoonho@catholic.ac.kr
- Recruiting
Pusan National University Yangsan Hospital
Yangsan
Kwonoh Park, parkkoh@hanmail.net
About this study
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
This study aims to verify superiority of pemetrexed maintenance to observation for patient without disease progression after 1 st line cisplatin-based chemotherapy.
Read the 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.
- Conditions
- Bladder Cancer, Ureter Cancer, Transitional Cell Carcinoma
- Being tested
- pemetrexed, Folic Acid, Vitamin B12 Injection, Dexamethasone
- Medical subject headings
- Urinary Bladder Neoplasms, Ureteral Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexedDrug
Also called Alimta
Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
Folic AcidDrug
Also called Folvite, FA-8, FaLessa
folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Vitamin B12 InjectionDrug
Also called Vitabee 12
vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
DexamethasoneDrug
Also called decadron
Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
| Study group | Role | What they receive |
|---|---|---|
| pemetrexed maintenance | Experimental | Drug: Pemetrexed Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Drug: folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
Drug: vitamin B12 injection 1000 μg IM 7 days prior to treatment initiation and the every then every 3 cycles until the end of treatment
Drug: dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment Receives: Drug: pemetrexed; Drug: Folic Acid; Drug: Vitamin B12 Injection; Drug: Dexamethasone |
| observation | No intervention | observation group will be observed with best supportive care until progressive disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Time between randomization and disease progression or death from any causes, whichever came first. Alive patients free of progression will be censored at the last follow-up
Measured: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months
Secondary outcomes (4)
objective response rate
Objective response rate will be measured according to RECIST 1.1
Measured: every 9 weeks, assess the best overall response from date of randomization until the date of first documented progression upto 24 months
Incidence of treatment-emergent adverse events
Safety assessed per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Measured: every 3 weeks for pemetrexed group, every 9 weeks for observation group from date of randomization until the date of first documented progression upto 24 months
overall survival
Time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off
Measured: From date of randomization until the date of death from any cause, assessed up to 1 year after the end of treatment
Quality of Life
QoL will be assessed by EORTC QLQ-C30 core questionaire
Measured: before randomization, then 9, 18, and 27 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Cancer Study Group
- Responsible party
- Principal investigator, JLee, Asan Medical Center
- Investigators
- Jae-Lyun Lee, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193788
- Sponsor's protocol ID
- KCSG GU16-05
- Acronym
- PREMIER
- Status last verified
- May 2017
- First submitted
- 13 Aug 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. doi: 10.1200/JCO.2000.18.17.3068.
PubMed 11001674Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
PubMed 23835707Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O, Delgado FM, Hurteloup P, Winquist E, Morsli N, Salhi Y, Culine S, von der Maase H. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009 Sep 20;27(27):4454-61. doi: 10.1200/JCO.2008.20.5534. Epub 2009 Aug 17.
PubMed 19687335Vaughn DJ, Broome CM, Hussain M, Gutheil JC, Markowitz AB. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002 Feb 15;20(4):937-40. doi: 10.1200/JCO.2002.20.4.937.
PubMed 11844814Sweeney CJ, Roth BJ, Kabbinavar FF, Vaughn DJ, Arning M, Curiel RE, Obasaju CK, Wang Y, Nicol SJ, Kaufman DS. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006 Jul 20;24(21):3451-7. doi: 10.1200/JCO.2005.03.6699.
PubMed 16849761Galsky MD, Moshier E, Krege S, Lin CC, Hahn N, Ecke T, Sonpavde G, Pond G, Godbold J, Oh WK, Bamias A. Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy. Urol Oncol. 2014 Jan;32(1):48.e1-8. doi: 10.1016/j.urolonc.2013.07.001. Epub 2013 Sep 18.
PubMed 24055428
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03193788
- Acronym / sponsor ID
- PREMIER / KCSG GU16-05
- Conditions
- Bladder Cancer, Ureter Cancer, Transitional Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korean Cancer Study Group
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pemetrexed maintenance | Experimental | Drug: pemetrexed, Drug: Folic Acid, Drug: Vitamin B12 Injection, Drug: DexamethasoneDrug: Pemetrexed Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation. Drug: folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment Drug: vitamin B12 injection 1000 μg IM 7 days prior to treatment initiation and the every then every 3 cycles until the end of treatment Drug: dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment |
| observation | No intervention | –observation group will be observed with best supportive care until progressive disease |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmation urothelial cancer of bladder, ureter, or renal pelvis.
- Patients must present with locally advanced, recurrent or metastatic disease not amenable to surgery, radiotherapy, or combined modality therapy with curative intent.
- Patients who were administered 4-6 cycles of cisplatin-based first line chemotherapy [GP (gemcitabine/cisplatin), classic MVAC (methotrexate/vinblastine/doxorubicin/cisplatin), or dose-dense MVAC] and were planned to undergo regular surveillance
- ce after confirmation of absence of disease progression on CT taken within 3 week after the administration of the last cycle of 1st line chemotherapy.
- For patients with recurrent disease who received prior adjuvant or neoadjuvant chemotherapy with cisplatin-containing regimen, the last administration of previous treatment should be administered at least 6 months before start date of 1st line chemotherapy.
Key exclusion criteria (8 listed)
- Prior systemic chemotherapy or immunotherapy for palliative aim before or after 1st line cisplatin-based chemotherapy. However, prior intravesical chemotherapy or immunotherapy is allowed.
- Disease progression during or after 1st line cisplatin-based chemotherapy
- Known CNS metastasis
- Diagnosis of any serious secondary malignancy within the last 2 years, except for adequately treated basal cell or squamous cell carcinoma of skin, early gastric carcinoma, early stage thyroid carcinoma, insignificant prostate carcinoma, or in situ carcinoma of cervix uteri
- Pregnancy or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexedAlso: AlimtaPemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle | Drug | pemetrexed maintenance |
| Folic AcidAlso: Folvite, FA-8, FaLessafolic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment | Drug | pemetrexed maintenance |
| Vitamin B12 InjectionAlso: Vitabee 12vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment | Drug | pemetrexed maintenance |
| DexamethasoneAlso: decadronDexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions | Drug | pemetrexed maintenance |
Primary outcome
progression free survival
Time frame: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months
Time between randomization and disease progression or death from any causes, whichever came first. Alive patients free of progression will be censored at the last follow-up
4 secondary outcomes
objective response rate
Time frame: every 9 weeks, assess the best overall response from date of randomization until the date of first documented progression upto 24 months
Incidence of treatment-emergent adverse events
Time frame: every 3 weeks for pemetrexed group, every 9 weeks for observation group from date of randomization until the date of first documented progression upto 24 months
overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 1 year after the end of treatment
Quality of Life
Time frame: before randomization, then 9, 18, and 27 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Results publication: PubMed 11001674von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. doi: 10.1200/JCO.2000.18.17.3068.
- Results publication: PubMed 23835707Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
- Results publication: PubMed 19687335Bellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O, Delgado FM, Hurteloup P, Winquist E, Morsli N, Salhi Y, Culine S, von der Maase H. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol. 2009 Sep 20;27(27):4454-61. doi: 10.1200/JCO.2008.20.5534. Epub 2009 Aug 17.
- Results publication: PubMed 11844814Vaughn DJ, Broome CM, Hussain M, Gutheil JC, Markowitz AB. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002 Feb 15;20(4):937-40. doi: 10.1200/JCO.2002.20.4.937.
- Results publication: PubMed 16849761Sweeney CJ, Roth BJ, Kabbinavar FF, Vaughn DJ, Arning M, Curiel RE, Obasaju CK, Wang Y, Nicol SJ, Kaufman DS. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol. 2006 Jul 20;24(21):3451-7. doi: 10.1200/JCO.2005.03.6699.
- Results publication: PubMed 24055428Galsky MD, Moshier E, Krege S, Lin CC, Hahn N, Ecke T, Sonpavde G, Pond G, Godbold J, Oh WK, Bamias A. Posttreatment prognostic nomogram for patients with metastatic urothelial cancer completing first-line cisplatin-based chemotherapy. Urol Oncol. 2014 Jan;32(1):48.e1-8. doi: 10.1016/j.urolonc.2013.07.001. Epub 2013 Sep 18.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Lyun Lee, MD, PhD principal investigator
Asan Medical Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pemetrexed, Folic Acid and Vitamin B12 Injection in people with Bladder Cancer and Ureter Cancer, run by Asan Medical Center at 21 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Lyun Lee, MD, PhD (82 2 3010 5977, jaelyun@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: Every 9 weeks, from date of randomization until the date of first documented progression upto 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193788, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.