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Urinary BladderPhase 2NCT03061630

A Prospective Study of Neoadjuvant Chemotherapy With Gemcitabine/Platinum in Muscle-Invasive or Locally-Advanced Urothelial Carcinoma of Bladder

A Phase 2 study testing Gemcitabine and Cisplatin in people with Urinary Bladder, run by Samsung Medical Center at 2 sites in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Previously-untreated, high-risk (>T3 and/or N+) muscle-invasive bladder cancer (MIBC) cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1 Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Urinary Bladder
What is being tested?
Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
2 sitesSouth Korea
Study dates
15 Feb 2017to Jun 2022
Phase
Phase 2
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be aged 20 years or more
  • Must have histologically or cytologically proven UC of bladder.
  • Must have histological evidence of high-risk muscle-invasive disease (i.e., T2~ T4) or clinically N+ disease. They must be considered to have no other treatment options than radical cystectomy.
  • Must have an ECOG performance status of 0 to 1
  • Must have a life expectancy of 6 months or more
  • At least 2 weeks since the last surgical procedures or biopsies prior to enrolment. Subjects must have recovered to <Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
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  • Adequate marrow function without growth factor support or transfusion dependency
  • Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault or MDRD formulas
  • Adequate hepatic function
  • Must agree to use an adequate method of contraception if the patient is sexually active, during and for 12 weeks after the completion of chemotherapy
  • Written and voluntary informed consent understood, signed and dated.

Who cannot join

  • Ongoing treatment with an anticancer agent not contemplated in this protocol
  • Radiologic finding consistent with metastatic disease
  • Severe medical or phychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation
  • Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
  • Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
  • Double primary cancer of other site(s) or a history of other malignancies, except for cured ones at the discretion of investigator
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  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Subjects who have exhibited allergic reactions to study treatment
  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study
  • Subject with legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Samsung Medical Center

    Seoul, 06351

  • Samsung Medical Center

    Seoul, 135710

Other trials in South Korea

About this study

Official title: SAMSUNG MEDICAL CENTER

Previously-untreated, high-risk (>T3 and/or N+) muscle-invasive bladder cancer (MIBC) cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1

Read the detailed description

Screening numbers are endowed to all patients who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with patient initials. Patients withdrawn from the study retain their screening number. New patients must always be allotted with a new screening number. The study population includes chemotherapy-naïve adults with high-risk MIBC. Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive cisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1, adequate hydration and antiemetics are needed. Study chemotherapy will repeat every 4 weeks on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 2 or 3 cycles, depending on the operation schedules.

Patients will be seen every 4 weeks. All study subjects will be also eligible to receive best supportive care (BSC) defined as any standard supportive measures that are not considered a primary treatment of the disease under study, including the use of growth factors (i.e. G-CSF) for myelosuppression, bisphosphonates for management of skeletal metastases, analgesics and transfusion of blood products. BSC will be provided at the discretion of the investigators.

Conditions
Urinary Bladder
Being tested
Gemcitabine, Cisplatin

What participants receive

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

Study groups in NCT03061630
Study groupRoleWhat they receive
gemcitabineExperimentalcisplatin 60 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on days 1, 8 and 15. On day 1
Receives: Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. pathologic response

    to determine the antitumor activity of study treatment in terms of pathologic response

    Measured: 30 months

Secondary outcomes (1)

  1. progression-free survival

    Measured: 30 months

Timeline

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

  1. First posted23 Feb 2017
  2. Study start15 Feb 2017
  3. Primary completionMar 2022 (estimated)
  4. Study completionJun 2022 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03061630
Sponsor's protocol ID
2017-01-006
Status last verified
Mar 2022
First submitted
20 Feb 2017
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Cisplatin in people with Urinary Bladder, run by Samsung Medical Center at 2 sites in South Korea.

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 11 inclusion and 10 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic response (time frame: 30 months). 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 NCT03061630.

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 8 Mar 2022.

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