Trial · NCT07000084
Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
NCT07000084, Phase 3, Recruiting, Alliance for Clinical Trials in Oncology
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy. Trials, record NCT07000084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07000084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
- NCT number
- NCT07000084
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 330 participants, estimated
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
- Interventions
- BCG Solution, Biopsy of Bladder, Cystoscopy, Computed Tomography, Magnetic Resonance Imaging, Biospecimen Collection, Transurethral Resection of Bladder Tumor, Gemcitabine
- First posted
- 2025-05-31
- Last updated
- 2026-10-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | High Grade Recurrence-free survival (HG-RFS) | Up to 5 years | HG-RFS will be calculated from randomization until the detection of a high-grade bladder cancer recurrence (biopsy proven intravesical recurrence or distant metastasis), cystectomy, or death, whichever occurs first. Patients who are alive and without documented high-grade recurrence will be censored at the time of last disease evaluation. HG-RFS will be compared between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group ( |
| Secondary | High-grade cancer free at 3 months | at 3 months | A patient will be classified as being cancer free if no high-grade bladder cancer is detected upon a cystoscopic biopsy (± transurethral resection of bladder tumor \[TURBT\]). This will be calculated as the number of patients who underwent cystoscopic biopsy with or without TURBT at 3 months and no high-grade cancer was detected, divided by the total number of patients. |
| Secondary | 6-month Complete Response | At 6 months | Complete response rate will be determined among patients who had carcinoma in situ (CIS) at baseline. Patients will be classified as having a complete response at 6 months if there is no biopsy-proven high grade bladder cancer detected based on a cystoscopy and urinary cytology (± biopsy/TURBT). This will be calculated as the number of patients who had CIS at baseline and who had no evidence of disease at 6-months, divided by the total number of patients who had CIS at baseline. The proportion of patients who remain with a complete response will be compared between the two arms with a chi-square test or Fisher's exact test. |
| Secondary | Durability of Response | Up to 5 years | o Durability of the response will be determined only in the patients who had CIS at baseline and had a complete response at 6 months. This will be measured as time from the 6-month evaluation until documented disease recurrence, censoring patients without disease recurrence at time of death or at last disease evaluation, whichever is last. The durability of response will be compared between the two treatment groups using a log-rank test, and Kaplan-Meier estimators will be used to determine the median durability. |
| Secondary | Recurrence-free survival | Up to 5 years | Recurrence-free survival will be calculated as the time from randomization until the detection of any grade bladder cancer, censoring those without documented disease recurrence at time of last disease evaluation or death, whichever occurs last. This will be compared between the two treatment arms using a stratified log-rank test. An estimate of the outcome differences between the arms will be made with a HR and 95% confidence interval generated by a stratified Cox model. |
| Secondary | Progression-free survival | up to 5 years | Progression-free survival will be calculated as the time from randomization until disease progression, defined as development of muscle invasive disease (stage greater than or equal to T2), lymph node or distant metastasis, or death without documented disease progression. This will be compared between the two treatment arms using a stratified log-rank test. An estimate of the outcome differences between the arms will be made with a HR and 95% confidence interval generated by a stratified Cox model. |
| Secondary | Cystectomy-free survival | up to 5 years | Cystectomy-free survival will be defined as the time from randomization until the patient undergoes a cystectomy, censoring patients without a cystectomy at last follow-up or death, whichever is last. This will be compared between the two treatment arms using a stratified log-rank test. An estimate of the outcome differences between the arms will be made with a HR and 95% confidence generated by a stratified Cox model. |
| Secondary | • Bacille Calmette Guerin (BCG)-unresponsive non muscle invasive bladder cancer free survival | up to 5 years | BCG unresponsive NMIBC free survival will be defined as time from randomization until the patient develops BCG unresponsive NMIBC, defined as persistent or recurrent high-grade papillary NMIBC (Ta/T1) \<6 months of "adequate" BCG (≥5 of 6 plus an additional ≥2 doses of BCG) or CIS (with or without Ta/T1 papillary disease) recurrence \<12 months of "adequate" BCG (≥5 of 6 plus an additional ≥2 doses of BCG) or High Grade T1 at week 13 (month 3) assessment. Patients who do not develop BCG-unresponsive NMIBC will be censored at the time of their last follow-up or death, whichever is last. This will be compared between the two treatment arms using a stratified log-rank test. An estimate of the outcome differences between the arms will be made with a HR and 95% confidence interval generated by a stratified Cox model. |
| Secondary | Rate of Grade 3+ Adverse Events | Up to 5 years | o Adverse events will be collected and graded according to the NCI Common Terminology Criteria for Adverse Events version 5.0. The number (percent) of patients that experience each grade 3+ adverse event will be summarized by treatment arm. In addition, the number (percent) of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized by treatment arm. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42821609 | DERIVED |
Source PubMed
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/NCT07000084
GET https://conductscience.org/api/trials/v1/NCT07000084/registered