Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004090-82 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel + Cisplatin chemotherapy | Experimental | Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel + Cisplatin chemotherapy | Drug | Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Pathological Response Rate | Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues. | Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival at 5 Years After Cystectomy | From registration until progression or death from any cause up to 5 years after surgery. Outcome is the percentage of patients who are progression free. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression. |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amit K Bahl | University Hospitals Bristol and Weston NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Haematology + Oncology Centre, Horfield Road | Bristol | BS2 8ED | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33727028 | Result | Challapalli A, Masson S, White P, Dailami N, Pearson S, Rowe E, Koupparis A, Oxley J, Abdelaziz A, Ash-Miles J, Bravo A, Foulstone E, Perks C, Holly J, Persad R, Bahl A. A Single-arm Phase II Trial of Neoadjuvant Cabazitaxel and Cisplatin Chemotherapy for Muscle-Invasive Transitional Cell Carcinoma of the Urinary Bladder. Clin Genitourin Cancer. 2021 Aug;19(4):325-332. doi: 10.1016/j.clgc.2021.02.001. Epub 2021 Feb 18. |
Not provided
Not provided
None. Screening as per the eligibility criteria. All eligible patients were registered into the trial and received the same treatment.
Recruitment took place at a single site, Bristol Haematology and Oncology Centre, Bristol, UK.. First patient was enrolled in July 2012 and the last in August 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cabazitaxel + Cisplatin Chemotherapy | Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cabazitaxel + Cisplatin Chemotherapy | Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients 18 years and over |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Pathological Response Rate | Pathological stage at diagnosis (T2/T3 - see baseline characteristics) was compared to pathological stage of the surgical specimen at cystectomy. A response is considered as a decrease in T stage from T2/T3 seen at baseline to T1 or less indicating a reduction in tumour size/invasiveness. The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues. | 28 patients were recruited. All completed trial treatment. 26 were analysed for the primary endpoint. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the primary endpoint analysis but included in toxicity analysis. | Posted | Number | 99% Confidence Interval | % of participants | Histological assessment of radical cystectomy specimen expected to be 15 weeks after commencing study chemotherapy. |
Adverse Events were monitored/assessed up to 5 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cabazitaxel + Cisplatin Chemotherapy | Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | CTCAE v4.03 | Non-systematic Assessment | G3, probably related, recovered |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.03 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Amit Bahl | University Hospitals Bristol and Weston NHS Foundation Trust | +44 117 342 6733 | amit.bahl@uhbw.nhs.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2017 | Dec 16, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2017 | Dec 16, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C552428 | cabazitaxel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From registration up to 5 years after surgery |
| Progression Free Survival of Patients Who Did Not Show Pathological Downstaging | From registration until progression or death from any cause up to 5 years after surgery. Outcome is the median number of months it takes 50% of patients to show progression. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression. | From registration up to 5 years after surgery |
| Overall Survival at 5 Years After Cystectomy | From registration until death from any cause up to 5 years after surgery. Outcome is the percentage of patients alive at 5 years after cystectomy. | From registration up to 5 years after cystectomy |
| Overall Survival of Patients Who Did Not Show Pathological Downstaging | From registration until death from any cause up to 5 years after surgery. Outcome is the median number of months it takes for 50% of patients to die. | From registration up to 5 years after cystectomy |
| Assessment of EQ-5D-5L Quality of Life | EQ-5D-5L will be assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of EQ-5D-5L VAS Score | EQ-5D-5L VAS score was assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of EORTC QLQ-C30 Score | EORTC QLQ-C30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete 30 questions and a combined summary score between 0-100 is derived from their answers. The higher the score the better their quality of life. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of BLM30 Urinary Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined urinary questions is shown. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of BLM30 Future Perspectives Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined future perspectives questions is shown. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of BLM30 Bloating/Flatulence Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined bloating/flatulence questions is shown. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of BLM30 Body Image Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined Body Image questions is shown. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Assessment of BLM30 Sexual Function Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined sexual functioning questions is shown. | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
| Mean |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) performance status | ECOG performance is graded from 0-5, where 0 is 'Fully active, able to carry on all pre-disease performance without restriction' and 5 is 'Dead'. All participants on the study had an ECOG performance status of 0 'Fully active' or 1 'Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work'. | Number | participants |
|
| eGFR | Median | Full Range | ml/min/1.73m^2 |
|
| Pathological T stage | The T stage describes how far the primary tumour has spread. The higher the stage the further the tumour has grown through the bladder wall and into the surrounding tissues. The stages are Ta - non-invasive papillary carcinoma, Tis - flat non-invasive carcinoma, T1 - grown through the connective tissue but not into the muscle of the bladder wall, T2 - tumour has grown through the connective tissue and into the muscle of the bladder wall, T3 - tumour has grown through the muscle and into the fatty layer surrounding the bladder and T4 - the cancer has spread to surrounding tissues. | Count of Participants | Participants |
|
|
|
|
| Secondary | Progression Free Survival at 5 Years After Cystectomy | From registration until progression or death from any cause up to 5 years after surgery. Outcome is the percentage of patients who are progression free. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the PFS analysis but included in toxicity analysis. | Posted | Number | % of participants | From registration up to 5 years after surgery |
|
|
|
| Secondary | Progression Free Survival of Patients Who Did Not Show Pathological Downstaging | From registration until progression or death from any cause up to 5 years after surgery. Outcome is the median number of months it takes 50% of patients to show progression. After cystectomy patients are tumour free. They are reviewed regularly and CT scans and further tests are requested if it is suspected that the tumour has returned. If there is evidence that the tumour has returned or if the patient dies from any cause this is considered to be progression. | Patients who did not show pathological downstaging after treatment are being analysed here - 11 in total. | Posted | Median | 95% Confidence Interval | months | From registration up to 5 years after surgery |
|
|
|
| Secondary | Overall Survival at 5 Years After Cystectomy | From registration until death from any cause up to 5 years after surgery. Outcome is the percentage of patients alive at 5 years after cystectomy. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 1 patient did not have surgery after trial treatment and was excluded from the OS analysis but included in toxicity analysis. | Posted | Number | % of participants | From registration up to 5 years after cystectomy |
|
|
|
| Secondary | Overall Survival of Patients Who Did Not Show Pathological Downstaging | From registration until death from any cause up to 5 years after surgery. Outcome is the median number of months it takes for 50% of patients to die. | Patients who did not show pathological downstaging after treatment are being analysed here - 11 in total. | Posted | Median | 95% Confidence Interval | months | From registration up to 5 years after cystectomy |
|
|
|
| Secondary | Assessment of EQ-5D-5L Quality of Life | EQ-5D-5L will be assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for the quality of life. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | EQ-5D index value | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of EQ-5D-5L VAS Score | EQ-5D-5L VAS score was assessed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for the quality of life. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | EQ-5D VAS score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of EORTC QLQ-C30 Score | EORTC QLQ-C30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete 30 questions and a combined summary score between 0-100 is derived from their answers. The higher the score the better their quality of life. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of BLM30 Urinary Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined urinary questions is shown. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of BLM30 Future Perspectives Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined future perspectives questions is shown. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of BLM30 Bloating/Flatulence Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined bloating/flatulence questions is shown. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of BLM30 Body Image Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined Body Image questions is shown. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| Secondary | Assessment of BLM30 Sexual Function Score | EORTC BLM30 questionnaire was completed at baseline, following each cycle of chemotherapy and at the end of chemotherapy prior to surgery. Patients are asked to complete questions which are split into 5 categories Urinary, Future perspectives, Bloating/flatulence, Body image and Sexual functioning. Each question has 4 possible answers from 'not at all' scored 1, to 'very much' scored 4. The scores for each different question in a category are combined and an overall score between 0-100 is derived from the answers. The higher the score the worse the symptom. In this outcome the score for the combined sexual functioning questions is shown. | 28 patients were recruited. All completed trial treatment. On review of imaging 1 patient was found to have had metastatic disease at baseline and was excluded from endpoint analysis. 27 were analysed for quality of life data. However, not all patients answered all questionnaires at all time points. | Posted | Mean | Standard Deviation | summary score | Baseline, pre-Cycle 2 (each cycle was 21 days), pre-Cycle 3, pre-Cycle 4, and end of treatment visit (up to 13 weeks) |
|
|
|
| 10 |
| 27 |
| 9 |
| 27 |
| 26 |
| 27 |
|
| Enterovesicular fistula | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G3, possibly related, recovered |
|
| Post-surgical infection | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G2, not related, recovered |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment | 2 incidents, different patients |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment | 2 incidents, different patients |
|
| Fever | General disorders | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G1, definitely related, recovered |
|
| Dehydration leading to low eGFR | Metabolism and nutrition disorders | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G1, unlikely to be related, recovered |
|
| Hematuria | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment | 2 incidents from 2 patients |
|
| Sinus tachycardia | Cardiac disorders | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G2, definitely related, recovered |
|
| Sepsis - urinary | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment | 1 incident - G4, definitely related, recovered |
|
| Constipation | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Tinnitis | Ear and labyrinth disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE v4.03 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE v4.03 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE v4.03 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Hypomagnesemia | Investigations | CTCAE v4.03 | Non-systematic Assessment |
|
| Low creatinine clearance | Investigations | CTCAE v4.03 | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v4.03 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.03 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
|
| Pre Cycle 3 |
|
|
| Pre Cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|
|
| Pre-cycle 3 |
|
|
| Pre-cycle 4 |
|
|
| End of treatment |
|
|