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Status unknownNCT01196403Updated Apr 1, 2011

Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer

A Phase 2 interventional study of questionnaire administration and quality-of-life assessment in Bladder Cancer, sponsored by Wales Cancer Trials Unit. Status unknown at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-01.

Sponsored by Wales Cancer Trials Unit · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).

Secondary

  • To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
  • To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
  • To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
  • To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)

OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo an open radical cystectomy.
  • Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).

Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.

After completion of study treatment, patients are followed up at 6 weeks, 3 months, and 6 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.

02

Conditions studied

  • Bladder Cancer

Keywords

  • transitional cell carcinoma of the bladder
  • squamous cell carcinoma of the bladder
  • adenocarcinoma of the bladder
  • stage I bladder cancer
  • stage II bladder cancer
  • stage III bladder cancer
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 92 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Wales Cancer Trials Unit is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
92 participants (estimated)

Interventions

  • Otherquestionnaire administration
  • Procedurequality-of-life assessment
  • Procedurerobot-assisted laparoscopic surgery
  • Proceduretherapeutic conventional surgery
  • Proceduretherapeutic laparoscopic surgery
06

What researchers measure

Primary outcomes

  1. Percentage of patients who consent to be randomized

Secondary outcomes

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

  2. 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

  3. Safety and efficacy

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

07

Study locations

4 of 4 sites recruiting
  • Addenbrooke's Hospital
    Cambridge, England CB2 0QQ, United Kingdom
    • Contact Person · Contact · 44-1223-245-151
    Recruiting
  • Guy's Hospital
    London, England SE1 9RT, United Kingdom
    • Contact Person · Contact · 44-20-7188-7188
    Recruiting
  • University College of London Hospitals
    London, England WC1E 6AU, United Kingdom
    Recruiting
  • Wales Cancer Trials Unit
    Cardiff, Wales CF11 9LJ, United Kingdom
    • Contact Person · Contact · 44-29-2019-6800
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01196403
Lead sponsor
Wales Cancer Trials Unit
First posted
Sep 8, 2010
Start date
Jan 2009
Primary completion
Dec 2010 (estimated)
Last update
Apr 1, 2011

Study contacts

John Kelly, MD
principal investigator · University College London Hospitals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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