NCT00028756

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2001

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 2, 2016

Status Verified

August 1, 2016

Enrollment Period

12.3 years

First QC Date

January 4, 2002

Last Update Submit

August 1, 2016

Conditions

Stage III Bladder CancerStage IV Bladder CancerTransitional Cell Carcinoma of the Bladder

Outcome Measures

Primary Outcomes (2)

  • 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.

    5 years

  • 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.

    5 years

Study Arms (2)

Arm I (immediate chemotherapy)

ACTIVE COMPARATOR

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

Drug: doxorubicin hydrochlorideDrug: gemcitabine hydrochlorideDrug: vinblastine sulfateDrug: methotrexateDrug: cisplatinBiological: filgrastim

Arm II (deferred chemotherapy)

EXPERIMENTAL

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

Drug: doxorubicin hydrochlorideDrug: gemcitabine hydrochlorideDrug: vinblastine sulfateDrug: methotrexateDrug: cisplatinBiological: filgrastim

Interventions

doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)
gemcitabine hydrochlorideDRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)
vinblastine sulfateDRUG

Given IV

Also known as: 29060-LE, Exal, Velban, Velbe, Velsar
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)
methotrexateDRUG

Given IV

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Arm I (immediate chemotherapy)Arm II (deferred chemotherapy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25498218DERIVED

Related Links

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

DoxorubicinGemcitabineVinblastineMethotrexatemerphosCisplatinFilgrastimGranulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesAminopterinPterinsPteridinesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Cora Sternberg, Dr.

    San Camillo Forlanini Hospitals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

January 1, 2014

Study Completion

July 1, 2014

Last Updated

August 2, 2016

Record last verified: 2016-08