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Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

Primary Purpose

Infiltrating Bladder Urothelial Carcinoma

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional health services research trial for Infiltrating Bladder Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ancillary-Correlative (late toxicity and QOL)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Overall survival

Full Information

NCT ID

NCT02688348

First Posted

February 10, 2016

Last Updated

July 22, 2020

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02688348

Brief Title

Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

Official Title

Prospective Study of Bladder-Preservation Chemo-Radiotherapy (Partial Bladder Hypo-fractionated Radiotherapy) for Patients With Muscle-Invasive Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Study Start Date

April 22, 2015 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

PRIMARY OBJECTIVES: I. To study health-related quality of life (HRQoL, or QOL) for patients undergoing protocol-based bladder-preservation chemo-radiation. OUTLINE: Patients complete the European Organization for Research and Treatment for Cancer (EORTC) QLQ-Bladder Cancer Muscle Invasive (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infiltrating Bladder Urothelial Carcinoma

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ancillary-Correlative (late toxicity and QOL)

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From the date of study entry up to 5 years

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 5 years

Title

Overall survival

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher King

Organizational Affiliation

UCLA / Jonsson Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA / Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

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