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Stage III Bladder CancerPhase 3NCT00028756

Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

A Phase 3 study testing doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine sulfate in people with Stage III Bladder Cancer and Stage IV Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Read more about this study

Who is it for?
Any age
What is being tested?
doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine sulfate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
No sites listed yet
Study dates
Oct 2001to Jul 2014
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histologically confirmed transitional cell carcinoma of the bladder urothelium
  • T3-4, N1-3, M0
  • No pure squamous cell or adenocarcinoma tumors
  • No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease
  • Performance status - WHO 0-1
  • WBC at least 3,500/mm^3
Show all 25Show fewer
  • Platelet count at least 120,000/mm^3
  • SGOT/SGPT less than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN
  • Bilirubin normal
  • Glomerular filtration rate greater than 60 mL/min
  • No clinically significant cardiac arrhythmia
  • No congestive heart failure
  • No complete bundle branch block
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study
  • Considered fit for cisplatin-containing combination chemotherapy
  • No clinically abnormal auditory function
  • No known hypersensitivity to E. coli-derived drug preparations
  • No grade 2 or greater peripheral neuropathy
  • No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)
  • No psychological, familial, sociological, or geographical condition that would preclude study involvement
  • No prior systemic chemotherapy
  • No prior radiotherapy to the bladder

Who cannot join

None listed.

About this study

Official title: Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients With pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder

Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare the overall and progression-free survival of patients with stage III or IV transitional cell carcinoma of the bladder urothelium treated with immediate versus deferred adjuvant chemotherapy after radical cystectomy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor status (pT1-2 vs pT3 vs pT4), and node status (node positive vs node negative with 15 or more nodes sampled vs node negative with less than 15 nodes sampled). Patients are randomized to one of two treatment arms.

ARM I: Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.

ARM II: Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.

Patients in both arms receive one of the following chemotherapy regimens to be determined by participating center:

REGIMEN A (Classical M-VAC): Patients receive classical M-VAC comprising methotrexate IV on days 1, 15 and 22; vinblastine IV on days 2, 15, and 22; and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days.

REGIMEN B (High-dose M-VAC): Patients receive high-dose M-VAC comprising methotrexate IV on day 1 and vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Patients also receive filgrastim (G-CSF subcutaneously once daily on days 4-10. Courses repeat every 14 days.

REGIMEN C (Gemcitabine and cisplatin): Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV on day 1 or 2. Courses repeat every 28 days.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK and EORTC.

Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • doxorubicin hydrochlorideDrug

    Also called ADM, ADR, Adria, Adriamycin PFS

    Given IV

  • gemcitabine hydrochlorideDrug

    Also called dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

    Given IV

  • vinblastine sulfateDrug

    Also called 29060-LE, Exal, Velban, Velbe

    Given IV

  • methotrexateDrug

    Also called amethopterin, Folex, methylaminopterin, Mexate

    Given IV

  • cisplatinDrug

    Also called CACP, CDDP, CPDD, DDP

    Given IV

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given SC

Study groups in NCT00028756
Study groupRoleWhat they receive
Arm I (immediate chemotherapy)Active comparatorBeginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.
Receives: Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: vinblastine sulfate; Drug: methotrexate; Drug: cisplatin; Biological: filgrastim
Arm II (deferred chemotherapy)ExperimentalBeginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.
Receives: Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: vinblastine sulfate; Drug: methotrexate; Drug: cisplatin; Biological: filgrastim

What is being measured

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

  1. Duration of survival

    Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status.

    Measured: 5 years

  2. Duration of progression-free survival

    Estimated using the Kaplan-Meier technique and compared based on a two sided logrank test with retrospective stratification for the participating cooperative group, the chemotherapy regimen, the T category and the nodal status.

    Measured: 5 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startOct 2001
  3. Primary completionJan 2014
  4. Study completionJul 2014

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
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028756
Sponsor's protocol ID
EORTC 30994
Other IDs
EORTC-30994, CDR0000069130, CAN-NCIC-EORTC-30994, ACOSOG-EORTC-30994, NCRI-BLADDER-EORTC-30994, UKCCCR-EORTC-30994, FNCLCC-GETUG-EORTC-30994, N02CM62212
Status last verified
Aug 2016
First submitted
4 Jan 2002
Last updated
2 Aug 2016
Results posted
No

Publications

  • Sternberg CN, Skoneczna I, Kerst JM, Albers P, Fossa SD, Agerbaek M, Dumez H, de Santis M, Theodore C, Leahy MG, Chester JD, Verbaeys A, Daugaard G, Wood L, Witjes JA, de Wit R, Geoffrois L, Sengelov L, Thalmann G, Charpentier D, Rolland F, Mignot L, Sundar S, Symonds P, Graham J, Joly F, Marreaud S, Collette L, Sylvester R; European Organisation for Research and Treatment of Cancer Genito-Urinary Cancers Group; Groupe d'Etude des Tumeurs Urogenitales; National Cancer Research Institute Bladder Cancer Study Group; National Cancer Institute of Canada Clinical Trials Group; German Association of Urologic Oncology. Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4 or N+ M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial. Lancet Oncol. 2015 Jan;16(1):76-86. doi: 10.1016/S1470-2045(14)71160-X. Epub 2014 Dec 11.

    PubMed 25498218

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine sulfate in people with Stage III Bladder Cancer and Stage IV Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC.

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 25 inclusion and 0 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: finished, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Duration of survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT00028756, which also lists 1 linked publication.

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 2 Aug 2016.

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