NCT02688348

Brief Summary

This research trial studies quality of life after bladder-preservation chemotherapy and radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into or through the muscle layer of the bladder (muscle-invasive bladder cancer). Bladder-preservation chemo-radiotherapy is a standard treatment for patients with muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel, and sexual late side effects that negatively affect patients' quality of life. Studying quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may help identify the long-term side effects of treatment and may help plan the best treatment in the future and improve patients' quality of life.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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 22, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

July 24, 2020

Status Verified

February 1, 2020

Enrollment Period

3.9 years

First QC Date

February 10, 2016

Last Update Submit

July 22, 2020

Conditions

Infiltrating Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Establish QOL with validated tools for patients undergoing bladder-preservation chemo-radiation

    Validated Quality-of-Life questionnaires developed by the European Organization for Research and Treatment for Cancer (EORTC) will be used. The EORTC QLQ-BLM30 with 30 questions specific to muscle-invasive bladder cancer will be combined and used in conjunction with the general cancer questionnaire EORTC QLQ-C30 (Aaronson).

    From the date of study entry up to 5 years

Secondary Outcomes (2)

  • Quantify the rate of early and late grade 3 or higher GU or GI toxicity based on the CTCAE criteria

    Up to 5 years

  • Overall survival

    From the date of study entry to the date of death, assessed up to 5 years

Study Arms (1)

Ancillary-Correlative (late toxicity and QOL)

OTHER

Patients complete the EORTC QLQ-BLM-C30 at baseline, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of chemo-radiotherapy.

Other: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Ancillary-Correlative (late toxicity and QOL)
Questionnaire AdministrationOTHER

Ancillary studies

Ancillary-Correlative (late toxicity and QOL)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded)
  • No pelvic nodal metastases or distant metastases (based on computed tomography \[CT\], positron emission tomography \[PET\] or magnetic resonance imaging \[MRI\])
  • Karnofsky performance status (KPS) \>= 70
  • Ability to understand, and willingness to sign, the written informed consent
  • Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable
  • Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate

You may not qualify if:

  • Patients with any evidence of distant metastases
  • Prior pelvic radiotherapy
  • History of Crohn's disease or ulcerative colitis
  • Unable to receive chemotherapy
  • Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Study Officials

  • Christopher King

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 23, 2016

Study Start

April 22, 2015

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

July 24, 2020

Record last verified: 2020-02

Locations

US(1)