Clinical trial NCT01196403: Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer
Official title: Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-09-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percentage of patients who consent to be randomized
Secondary outcomes:
measure: Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
measure: 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
measure: Safety and efficacy
measure: Quality of life data measuring return to normal activities (physical, social, and occupational)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: London
country: United Kingdom
facility: Guy's Hospital
state: England
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
city: Cardiff
country: United Kingdom
facility: Wales Cancer Trials Unit
state: Wales
Study officials:
affiliation: University College London Hospitals
name: John Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References: