NCT00006111

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may be an effective way to treat cancer of the urinary tract. PURPOSE: Phase II trial to study the effectiveness of combining surgery, chemotherapy and radiation therapy in treating patients who have stage II, stage III, or stage IV cancer of the urinary tract .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_2

Geographic Reach
1 country

11 active sites

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

April 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 3, 2004

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

August 3, 2000

Last Update Submit

February 18, 2021

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer

Keywords

stage II bladder cancerstage III bladder cancerstage IV bladder canceranterior urethral cancerposterior urethral cancerurethral cancer associated with invasive bladder cancermetastatic transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureter

Study Arms (2)

resectable disease

EXPERIMENTAL
Drug: cisplatinDrug: fluorouracilProcedure: conventional surgeryRadiation: radiation therapy

unresectable disease

EXPERIMENTAL
Drug: cisplatinDrug: fluorouracilRadiation: radiation therapy

Interventions

cisplatinDRUG
resectable diseaseunresectable disease
fluorouracilDRUG
resectable diseaseunresectable disease
conventional surgeryPROCEDURE
resectable disease
radiation therapyRADIATION
resectable diseaseunresectable disease

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV carcinoma of the urothelium infiltrating muscle Primary OR After development of a superficial tumor T2-T4b with or without lymph node involvement and no detectable metastases No epidermoid cancer or adenocarcinoma No extrapelvic lymph node involvement PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: More than 6 months Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Neutrophil count greater than 1,500/mm3 Hemoglobin greater than 10 g/dL Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL Other: Not pregnant Fertile patients must use effective contraception during and for 2 months after study No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No prior serious illness of the gastrointestinal tract (e.g., rectal bleeding or diverticulosis with complications) No contraindication to fluorouracil, cisplatin, or radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy except intravesicular instillations Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (11)

Institut Sainte Catherine

Avignon, 84082, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

C.H.U. - Hopital Gaston Doumergue

Nîmes, 30006, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Hospitalier General de Saint Nazaire

Saint-Nazaire, 44600, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUrethral Neoplasms

Interventions

CisplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Jean-Leon Lagrange, MD

    Centre Antoine Lacassagne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

February 3, 2004

Study Start

April 1, 1999

Primary Completion

January 1, 2003

Study Completion

June 1, 2008

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

FR(11)