Clinical trial · Interventional
Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors
Phase II Trial of Estrogen Receptor Targeted Treatment of Non-Muscle Invasive Bladder Cancer With Tamoxifen.
NCT02197897CI-TRIAL-00049400BCTamoxifencompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tamoxifen Citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tamoxifen
- description
- 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.
- interventionNames
- Drug: Tamoxifen Citrate
Primary outcomes (1)
- measure
- Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion
- timeFrame
- 2.5 years
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Males and females age 21 or older. Histologic evidence of urothelial carcinoma of the bladder. Low/Intermediate-risk papillary urothelial carcinoma of the bladder, at initial occurrence or recurrent with \>6 months interval free of disease. Patients with multifocal tumors must have resectable lesions. Patients may be treatment-naïve or have failed 1 previous regimen of intravesical therapy. At least one endoscopically measurable tumor 6 - 10mm in diameter. Adequate hepatic and renal function. Patient or authorized proxy needs to have signed the informed consent form. \- Exclusion Criteria: Patients with sessile appearing tumors, which may be invasive or high-grade. Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract. Plans for pelvic radiation while participating in the study. Concurrent use of warfarin, heparin, or chronic use of NSAIDs, including aspirin (other than cardioprotective doses of 80mg daily) within 30 days prior to registration or during the trial. Concurrent use of selective serotonin reuptake inhibitors or aromatase inhibitors. Chronic or acute renal or hepatic disorder or any other condition, medical or psychological that, in the opinion of the investigator, could jeopardize the subject's safe participation. Any other investigational drug within 30 days prior to registration and during the study. Women Exclusion Pregnant or lactating women. Personal history of endometrial cancer or any abnormal uterine bleeding. Previous or concurrent treatment with SERM and/or hormonal replacement therapy within 3 months of the study. \-
References
Publications (0)
Data not yet available
No reference posted for this study.