NCT01196403

Brief Summary

RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer. PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

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

January 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

April 1, 2011

Status Verified

September 1, 2010

Enrollment Period

1.9 years

First QC Date

September 4, 2010

Last Update Submit

March 31, 2011

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladdersquamous cell carcinoma of the bladderadenocarcinoma of the bladderstage I bladder cancerstage II bladder cancerstage III bladder cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who consent to be randomized

Secondary Outcomes (4)

  • Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization

  • Potential factors relating to non-registration of patients who are eligible for inclusion but have not been registered based on review of anonymous screening logs

  • Safety and efficacy

  • Quality of life data measuring return to normal activities (physical, social, and occupational)

Interventions

questionnaire administrationOTHER
quality-of-life assessmentPROCEDURE
robot-assisted laparoscopic surgeryPROCEDURE
therapeutic conventional surgeryPROCEDURE
therapeutic laparoscopic surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histopathologically confirmed bladder cancer, including any of the following cell types: * Urothelial cell (transitional cell) carcinoma * Squamous cell carcinoma * Adenocarcinoma * Stage pT1, pT2, or pT3 disease OR mobile bladder mass on bimanual examination under anesthesia * No enlarged nodes or distant metastases on CT or MRI scan of the abdomen and pelvis * No upper urinary tract disease PATIENT CHARACTERISTICS: * American Society of Anesthesiologist (ASA) status 1-3 * Life expectancy \> 24 months * Not pregnant or nursing * Negative pregnancy test * No concurrent disease that would render the patient unsuitable for the trial * No presence of urosepsis PRIOR CONCURRENT THERAPY: * May have received prior neoadjuvant chemotherapy provided study surgery is performed between 3 and 10 weeks from the date of the completion of chemotherapy treatment

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

Sponsors & Collaborators

Study Sites (4)

Addenbrooke's Hospital

Cambridge, England, CB2 0QQ, United Kingdom

RECRUITING

Guy's Hospital

London, England, SE1 9RT, United Kingdom

RECRUITING

University College of London Hospitals

London, England, WC1E 6AU, United Kingdom

RECRUITING

Wales Cancer Trials Unit

Cardiff, Wales, CF11 9LJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Kelly, MD

    University College London Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2010

First Posted

September 8, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Last Updated

April 1, 2011

Record last verified: 2010-09

Locations

GB(4)