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Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

gemcitabine plus cisplatin

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, neoadjuvant chemotherapy, gem/cis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age
histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
bone marrow reserve (neutrophil count >1500 cells per μL,platelet count >100 000 per μL) count
hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal).
renal function with a creatinine clearance >60ml/min

Exclusion Criteria:

metastatic disease
serious or uncontrolled concurrent medical illness
pregnancy
history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma)
non-transitional cell bladder cancer
creatinine clearance <60ml/min

Sites / Locations

Barmherzige Brüder Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gemcitabine plus cisplatin

Arm Description

gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied

Outcomes

Primary Outcome Measures

pathologic response rate

evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy

Secondary Outcome Measures

safety, number of participants with adverse events and grade of adverse events

to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer

Full Information

NCT ID

NCT01801644

First Posted

February 15, 2013

Last Updated

February 28, 2013

Sponsor

Barmherzige Brüder Vienna

1. Study Identification

Unique Protocol Identification Number

NCT01801644

Brief Title

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

Official Title

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barmherzige Brüder Vienna

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.

Detailed Description

Patients with locally advanced transitional cell bladder cancer receive 3 cycles of neoadjuvant gemcitabine/cisplatin before radical cystectomy. Patients with histologically confirmed clinical stage T2-T4a, N0-2 bladder cancer are going to be included. After CT scan of the thorax and abdomen plus MRI of the pelvis patient receive chemotherapy. Pathologic response rate will be assessed after surgery by the institutional pathologic review. Safety is going to be assessed according to the National Cancer Institute Common Toxicity Criteria (CTC,version 3.0).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

bladder cancer, neoadjuvant chemotherapy, gem/cis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

gemcitabine plus cisplatin

Arm Type

Experimental

Arm Description

gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied

Intervention Type

Drug

Intervention Name(s)

gemcitabine plus cisplatin

Other Intervention Name(s)

gemzar (gemcitabine) plus cisplatin (= cisplatin)

Intervention Description

gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion

Primary Outcome Measure Information:

Title

pathologic response rate

Description

evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy

Time Frame

at time of surgery

Secondary Outcome Measure Information:

Title

safety, number of participants with adverse events and grade of adverse events

Description

to assess the safety of neoadjuvant gemcitabine/cisplatin in bladder cancer

Time Frame

adverse events will be evaluated after every 6 months

Other Pre-specified Outcome Measures:

Title

progression free survival (PFS)

Description

pfs will be assessed avery 3 months in the first year after radical cystectomy, every 6 months in the second year, and yearly from the 3rd year up to a minimum follow up of 5 years

Time Frame

up to 5 years after including the last patient

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2 Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 bone marrow reserve (neutrophil count >1500 cells per μL,platelet count >100 000 per μL) count hepatic function (serum bilirubin <2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal). renal function with a creatinine clearance >60ml/min Exclusion Criteria: metastatic disease serious or uncontrolled concurrent medical illness pregnancy history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma) non-transitional cell bladder cancer creatinine clearance <60ml/min

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johannes Meran, M.D.

Organizational Affiliation

Barmherzige Brüder Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barmherzige Brüder Vienna

City

Vienna

ZIP/Postal Code

1020

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

18823036

Citation

Dash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848.

Results Reference

background

Citation

Tolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; Barmherzige Brueder Hospital, Vienna, Austria; Goettlicher Heiland Hospital, Vienna, Austria ´ J Clin Oncol 29: 2011 (suppl 7; abstr 296)

Results Reference

result

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Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

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