Trial Outcomes & Findings for Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC) (NCT NCT01663285)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

2 years after participant surgery

Results posted on

2015-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Neoadjuvant Gemcitabine and Cisplatin Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant Gemcitabine and Cisplatin n=1 Participants Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Age, Continuous	46 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years after participant surgery

Population: Due to poor patient enrollment the primary objective was not able to be analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 51 months

Population: Due to poor patient enrollment this outcome was not able to be analyzed.

The proportion of patients with pathologic T0/Tis/Ta N0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 years

Population: Due to poor patient enrollment this outcome was not able to be analyzed.

The safety of neoadjuvant chemotherapy.

Outcome measures

Outcome data not reported

Adverse Events

Neoadjuvant Gemcitabine and Cisplatin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Neoadjuvant Gemcitabine and Cisplatin n=1 participants at risk Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Renal and urinary disorders Acute Kidney Injury	100.0% 1/1 • Number of events 1
Investigations Creatinine Increased	100.0% 1/1 • Number of events 1
Metabolism and nutrition disorders Dehydration	100.0% 1/1 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hypoxia	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ajjai Alva

University of Michigan Comprehensive Cancer Center

Phone: 734-647-8921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place