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Bladder CancerPhase 3NCT00146276

Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer

A Phase 3 study testing gemcitabine in people with Bladder Cancer and Carcinoma, Transitional Cell, run by Association of Urologic Oncology (AUO) at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Primary Objective: To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer, Carcinoma, Transitional Cell
What is being tested?
gemcitabine
How many people
178 participants
Where
1 siteGermany
Study dates
Jul 2000to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Status after radical cystectomy for transitional cell carcinoma of the bladder, stages pT3a, pT3b, pT4a and/or pN1, pN2 (but no more than 5 lymph nodes positive for tumor) [International Union Against Cancer (UICC) criteria, 1997]. Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. Complete tumor removal by radical operation has to be established macroscopically and microscopically (R0 resection).
  • Patients regarded as inappropriate for cisplatin-based chemotherapy (i.e. impaired renal function with at least 30 ml/min calculated creatinine clearance and serum-creatinine less than 3.0 mg/dl, age > 70) are eligible for study enrollment [calculation of creatinine clearance according to Cockcroft and Gault formula]. Decision left to the investigator's discretion.
  • Patient has no prior history of systemic chemotherapy regimens. Previous local intravesical adjuvant chemotherapy or immunotherapy is allowed.
  • Prior radiation therapy is allowed if it has been completed at least 12 weeks before enrollment into the study and the patient has recovered from all toxic effects.
  • Performance status of 60 or higher on the Karnofsky Scale.
  • Patient compliance, mental state, and geographic proximity allow adequate followup
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  • Adequate bone marrow reserve: white blood cell (WBC) count >= 3.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 10 g/dL (or >= 6.2 mmol/L or >= 100 g/L).
  • Adequate liver function with bilirubin < 1.25 times above upper limit of normal range; alanine transaminase (ALT) or aspartate transaminase (AST) < 2.5 times normal upper limit.
  • Males or females at least 18 years of age who are considered fit for gemcitabine chemotherapy.
  • Signed informed consent by the patient.

Who cannot join

  • Tumor was not completely removed (visible tumor or enlarged lymph nodes left or positive margins microscopically-R1 or R2 resection)
  • Patient has a distant metastasis or metastases.
  • Tumor stage pT4b or more than 5 locoregional lymph nodes are positive for tumor.
  • Adeno- and/or squamous cell carcinoma of the bladder without transitional cell carcinoma component (different responses to chemotherapy).
  • Time interval between radical cystectomy and the first day of chemotherapy exceeds 3 months for patients enrolled in the treatment arm.
  • Serum creatinine >= 3.0 mg/dl (>= 265 mmol/l)
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  • Active infection (at the discretion of the investigator) .
  • Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
  • Patients with a history of prior malignancy other than basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or incidental carcinoma of the prostate must be clinically free of disease for at least 5 years prior to study entry.
  • Use of any investigational agent in the month before enrollment into the study.
  • White blood cell (WBC) count < 3.5 x 10^9/L or platelets < 100 x 10^9/L or hemoglobin < 10 g/dL (or < 6.2 mmol/L or < 100 g/L).
  • Bilirubin >= 1.25 times above upper limit of normal range; alanine transaminase (ALT) or aspartate transaminase (AST) >= 2.5 times upper limit of normal range

Trial locations and contacts

1 site in 1 country.

Jan Lehmann, MD contact

+49-(0)6841-1624700

jan.lehmann@uniklinikum-saarland.de

Michael Stöckle, MD contact

+49-(0)6841-1624700

michael.stoeckle@uniklinikum-saarland.de

Germany1 site, 1 recruiting

  • Saarland University

    Homburg/Saar, Saarland, 66421

    Jan Lehmann, MD, +49-(0)6841-1624700, jan.lehmann@uniklinikum-saarland.de

    Michael Stöckle, MD, +49-(0)6841-1624702, michael.stoeckle@uniklinikum-saarland.de

    Recruiting

Other trials in Germany

About this study

Official title: Adjuvant vs. Progression-Triggered Treatment With Gemcitabine After Radical Cystectomy for Locally Advanced Transitional Cell Carcinoma of the Bladder in Patients Not Suitable for Cisplatin-Based Chemotherapy - A Phase 3 Study

Primary Objective:

  • To analyse time to tumor progression in patients cystectomized for locally advanced transitional cell carcinoma (TCC) of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.
Read more

Secondary Objectives:

The secondary objectives of this study are:

  • Estimation of time-specific survival probabilities irrespective of causes of death.
  • Assessment of toxicity and tolerability of gemcitabine
  • Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy.
  • Assessment of quality of life (European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30).

Study Design:

This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study using gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:

Arm A (treatment): gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and 8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin treatment until 3 months after radical operation (within first 6 weeks is recommended).

Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only conditionally in case of progression with gemcitabine (dose and schedule as in arm A).

Read the detailed description

Primary Objective:

  • To analyse time to tumor progression in patients cystectomized for locally advanced TCC of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e. postoperative reduced renal function, advanced age). Patients are randomized to receive either adjuvant Gemcitabine immediately after radical operation (treatment arm A) or no treatment (control arm B). Patients in the control arm are to be treated with Gemcitabine as soon as tumor progression becomes evident clinically and/or radiologically.

Secondary Objectives:

The secondary objectives of this study are:

  • Estimation of time-specific survival probabilities irrespective of causes of death.
  • Assessment of toxicity and tolerability of Gemcitabine
  • Description of survival experience of patients in the control arm beyond the time of initiating chemotherapy.
  • Assessment of quality of life (EORTC QLQ-C30).

Study Design:

This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study using Gemcitabine as a single agent in chemonaive cystectomy patients with locally advanced TCC of the bladder in an adjuvant setting. The patients will receive the following treatment:

Arm A (treatment): Gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and 8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin treatment until 3 months after radical operation (within first 6 weeks is recommended).

Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only conditionally in case of progression with Gemcitabine (dose and schedule as in arm A).

Being tested
gemcitabine
Keywords
bladder cancer, cystectomy, gemcitabine, adjuvant chemotherapy, locally advanced bladder cancer
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

Secondary outcomes (3)

  1. overall survival

  2. toxicity and tolerability of gemcitabine

  3. quality of life (EORTC QLQ-C30, version 2.0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startJul 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146276
Sponsor's protocol ID
B9E-MC-S062
Other IDs
AB 22/00
Status last verified
Sep 2005
First submitted
2 Sep 2005
Last updated
27 Sep 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine in people with Bladder Cancer and Carcinoma, Transitional Cell, run by Association of Urologic Oncology (AUO) at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Lehmann, MD (+49-(0)6841-1624700, jan.lehmann@uniklinikum-saarland.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2006; AzTrials last refreshed its copy on 6 Nov 2026.

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