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Completed

NCT Number: NCT01801644

Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer

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

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barmherzige Brüder Vienna

Vienna, State of Vienna, 1020, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine plus cisplatin

Drug

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

Other names: gemzar (gemcitabine) plus cisplatin (= cisplatin)

Primary outcomes

  1. pathologic response rate

    Time frame: at time of surgery

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

Secondary outcomes

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

    Time frame: adverse events will be evaluated after every 6 months

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

Other outcomes

  1. progression free survival (PFS)

    Time frame: up to 5 years after including the last patient

    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

Sponsors and collaborators

Lead sponsor

Barmherzige Brüder Vienna

Other

Registry information

Official study title

Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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