Proton therapy and IMRT in Urothelial Carcinoma of the Bladder - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Urothelial Carcinoma of the Bladder

Intervention / Treatment

Detailed Description

Invasive urothelial bladder cancer is a common malignancy causing 14,000 deaths annually in the United States. The primary objective of the feasibility/Phase I portion of the study is to establish the feasibility and safety of proton and the safety of IMRT. Safety will be based on acute toxicity. The primary objective of the phase II study is to generate estimates of the local failure rate for intermediate and high risk patients treated with either proton therapy or IMRT. The study, however, is not explicitly designed to compare outcomes of proton therapy and IMRT. Secondary objectives include further evaluation of acute and late toxicity, quality of life and estimation of overall survival.

Study Type

Interventional

Enrollment (Actual)

2

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Pure or mixed variant urothelial carcinoma o Allowable mixed variant subtypes include: squamous differentiation glandular differentiation nested pattern microcystic micropapillary lymphoepthelioma-like plasmacytoid and lymphoma-like sarcomatoid/carcinosarcoma giant cell trophoblastic differentiation clear cell lipid cell undifferentiated Radical cystectomy and pelvic lymph node dissection within the prior 48 weeks Pathologic T3 or higher stage disease, N0-2, M0 (AJCC, 7th Ed., Appendix C) No clinical evidence of residual or recurrent disease based on the following minimum diagnostic work-up within 8 weeks of a patients consent to participate.
- History and physical examination
- Chest imaging by x-ray (PA and lateral views) or CT scan (with or without IV contrast);
- Axial abdominal and pelvic imaging by MRI (preferably with gadolinium)
- Bone scan
- Patients with microscopically involved (positive) surgical margins, but no grossly evident residual disease by imaging or physical exam are eligible.

The patient is a candidate for definitive external beam radiotherapy;

No prior radiotherapy to the region of study;
No inflammatory bowel disease, active collagen vascular or connective tissue disorders, and no other medical or social contraindications to radiotherapy, as determined by a participating radiation oncologist; Age ³18 years ECOG performance status: 0-2 Concurrent noninvestigational medications will be permitted Informed consent: Patients must have the ability to understand and be willing to sign the study-specific informed consent indicating their understanding of the investigational nature and the risks of this study before any of the protocol related studies are preformed (this does not include routine laboratory testing or imaging studies required to establish study eligibility);

Exclusion Criteria:

Unstable renal function in the month prior to registration defined as a creatinine rise of 1 mg/dL Prior partial or complete small bowel obstruction either before or after radical cystectomy Prior radiotherapy to the pelvis; o Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participants prior and current course of radiation therapy, radiotherapy was completed more than four weeks from enrolling in this study.

Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments o Prior chemotherapy or investigational drug for bladder cancer or a different cancer is allowed, provided that: The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation The participant has recovered to Grade 1 toxicity from agents previously administered Subtotal surgical resection with clinically evident residual disease by physical exam or axial imaging.

Prior or concurrent second invasive malignancy other than prostate and non-melanoma skin cancers, unless disease free for a minimum of five years. If a patient had a concurrent prostate cancer, then it must have been resected to negative margins.

Known severe, active co-morbidity, defined as follows:

o Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patients ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events Time Frame: withion 14 days of estimated date of treatment completion	Applies to Proton only	withion 14 days of estimated date of treatment completion
Number of Participants With Adverse Events Time Frame: within 90 days of radiation therapy	Applies to Both Proton and IMRT	within 90 days of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events Time Frame: later than 90 days from start of radiation therapy	Late toxicty	later than 90 days from start of radiation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 25, 2012

First Submitted That Met QC Criteria