Trial Outcomes & Findings for Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy (NCT NCT02145390)
NCT ID: NCT02145390
Last Updated: 2018-08-28
Results Overview
Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.
TERMINATED
NA
1 participants
2 years
2018-08-28
Participant Flow
Participant milestones
| Measure |
TURBT, NAC and Chemoradiation
* Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT);
* Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;
* For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;
* For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;
* Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);
* International Prostate Symptom Score (IPSS).
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TURBT, NAC and Chemoradiation
* Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT);
* Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;
* For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;
* For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;
* Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);
* International Prostate Symptom Score (IPSS).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Chemoradiation for Bladder Preservation After Complete Response to Neoadjuvant Chemotherapy
Baseline characteristics by cohort
| Measure |
TURBT, NAC and Chemoradiation
n=1 Participants
* Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT);
* Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;
* For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;
* For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;
* Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);
* International Prostate Symptom Score (IPSS).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
The two year rate of failure free survival (FFS) in study participants. This will include locoregional recurrence, and distant metastases. FFS is defined as absence of any failures (locoregional, distant metastasis, and death) during the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 years Post-TreatmentPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
The rate of acute and late grade 2 or higher (CTCAE v4.0) treatment-related genitourinary (GU), gastrointestinal (GI) and hematologic toxicity of bladder preservation in study participants.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
Rate of Overall Survival in Study Participants. Overall survival (OS) is defined as the time elapsed from the start of neoadjuvant chemotherapy until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year Post-Treatment, About 2 yearsPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
To evaluate known predictive and prognostic biomarkers for complete response to neoadjuvant chemotherapy and bladder preservation. Blood, urine and tumor tissue will be collected pre- and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 year Post-Treatment, About 2 yearsPopulation: A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.
To perform exploratory molecular analysis to identify new predictive and prognostic biomarkers for response to neoadjuvant chemotherapy, and bladder preservation. Blood, urine and tumor tissue for muscle invasive bladder cancer. Blood, urine and tumor tissue will be collected pre and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.
Outcome measures
Outcome data not reported
Adverse Events
TURBT, NAC and Chemoradiation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TURBT, NAC and Chemoradiation
n=1 participants at risk
* Transurethral Resection of the Bladder Tumor \& Cystoscopy (TURBT);
* Neoadjuvant Chemotherapy (NAC), per standard of care: Cisplatin and Gemcitabine therapy, within 8 weeks following the TURBT and cystoscopic evaluation;
* For subjects with complete response (CR): Chemoradiation within 6 weeks after post-neoadjuvant evaluation. Intensity Modulated Radiation Therapy (IMRT/VMAT); Cisplatin therapy per standard of care;
* For subjects who have pT1 or worse tumor response: Radical Cystectomy, per standard of care, within 12 weeks post-neoadjuvant chemotherapy evaluation;
* Expanded Prostate Cancer Index Composite Short Form 12 (EPIC SF-12);
* International Prostate Symptom Score (IPSS).
|
|---|---|
|
Gastrointestinal disorders
Bloating
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
|
General disorders
Pain
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 3 • Up to 2 years Post-Treatment
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
100.0%
1/1 • Number of events 1 • Up to 2 years Post-Treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place