Trial · NCT01663285
Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)
NCT01663285, Phase 2, Terminated, University of Michigan Rogel Cancer Center; results first posted 2014-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC). Trials, record NCT01663285. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01663285
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)
- NCT number
- NCT01663285
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Urothelial Cancer, Bladder Cancer
- Interventions
- Neoadjuvant Cisplatin and Gemcitabine
- First posted
- 2012-08-13
- Last updated
- 2015-12-03
- Results first posted
- 2014-09-18
- Limitations and caveats
- The study was terminated prematurely due to poor patient accrual. Study objectives were not analyzed.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free Survival Time | 2 years after participant surgery | The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma. |
| Secondary | Number of Patients With Pathologic T0/Tis/Ta N0. | 51 months | The proportion of patients with pathologic T0/Tis/Ta N0. |
| Secondary | Number of Participants With Adverse Events | 9 years | The safety of neoadjuvant chemotherapy. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recurrence-free Survival Time | 2 years after participant surgery | Due to poor patient enrollment the primary objective was not able to be analyzed. | ||
| SECONDARY | Number of Patients With Pathologic T0/Tis/Ta N0. | 51 months | Due to poor patient enrollment this outcome was not able to be analyzed. | ||
| SECONDARY | Number of Participants With Adverse Events | 9 years | Due to poor patient enrollment this outcome was not able to be analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neoadjuvant Gemcitabine and Cisplatin | 1 | |
| Overall Study | COMPLETED | Neoadjuvant Gemcitabine and Cisplatin | 1 | |
| Overall Study | NOT COMPLETED | Neoadjuvant Gemcitabine and Cisplatin | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Acute Kidney Injury | Renal and urinary disorders | Neoadjuvant Gemcitabine and Cisplatin | 1 | 1 | 1 |
| serious | Creatinine Increased | Investigations | Neoadjuvant Gemcitabine and Cisplatin | 1 | 1 | 1 |
| serious | Dehydration | Metabolism and nutrition disorders | Neoadjuvant Gemcitabine and Cisplatin | 1 | 1 | 1 |
| serious | Hypoxia | Respiratory, thoracic and mediastinal disorders | Neoadjuvant Gemcitabine and Cisplatin | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neoadjuvant Gemcitabine and Cisplatin | ||
| Total, other adverse events | Neoadjuvant Gemcitabine and Cisplatin | 0 | 1 |
| Total, serious adverse events | Neoadjuvant Gemcitabine and Cisplatin | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01663285
GET https://conductscience.org/api/trials/v1/NCT01663285/registered