Trial Outcomes & Findings for Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors (NCT NCT02197897)
NCT ID: NCT02197897
Last Updated: 2021-01-13
Results Overview
Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
2.5 years
Results posted on
2021-01-13
Participant Flow
Subjects will be identified from the Scott Department of Urology (SDU) and Affiliated Institutions.Patients will be informed verbally and in writing about the study, procedures involved. They will be given adequate opportunity to read it and discuss with family before it is signed. Participation in this study will last about 4 months.
Participant milestones
| Measure |
Tamoxifen
As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tamoxifen
As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)
|
|---|---|
|
Overall Study
not eligible
|
1
|
Baseline Characteristics
Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Baseline characteristics by cohort
| Measure |
Tamoxifen
n=13 Participants
As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Ethinicity · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Ethinicity · Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race Ethinicity · White
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 yearsEvaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response
Outcome measures
| Measure |
Tamoxifen
n=14 Participants
As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)
|
|---|---|
|
Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion
|
13 Participants
|
Adverse Events
Tamoxifen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tamoxifen
n=13 participants at risk
As a single-arm study (single group assignment), Tamoxifen citrate will be given to all patients at a 20mg/day dose for 12 weeks using a marker-lesion study design.
Tamoxifen Citrate: Single-center, two-stage phase-II clinical trial (Simon design)
|
|---|---|
|
Blood and lymphatic system disorders
Hematuria
|
23.1%
3/13 • Number of events 3 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Gastrointestinal disorders
Urinary Tract Pain
|
15.4%
2/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Renal and urinary disorders
Urinary Frequency
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
15.4%
2/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Cardiac disorders
Thromboembolic event
|
15.4%
2/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Cardiac disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 3 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Cardiac disorders
Sinus Bradycardia
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Cardiac disorders
Sinus Tachycardia
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
General disorders
Edema limbs
|
15.4%
2/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Cardiac disorders
Non Cardiac Chest Pain
|
15.4%
2/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Platelet Count decreased
|
15.4%
2/13 • Number of events 3 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Blood Bilirubin Increase
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
creatinine increase
|
7.7%
1/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Lymphocyte Count decrease
|
7.7%
1/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
15.4%
2/13 • Number of events 3 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
7.7%
1/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Eye disorders
Eye Disorders
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
General disorders
Abdominal Pain
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
General disorders
Erectile Dysfunction
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
General disorders
Dyspenia
|
7.7%
1/13 • Number of events 2 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo- Papular
|
7.7%
1/13 • Number of events 1 • Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.
Toxicity events were recorded utilizing the Common Terminology Criteria for Adverse Events version 4.02 (CTCAE v4.02). Figure 1 illustrates the study linear chronogram schema.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place