Adjuvant Proton Therapy or IMRT for the Treatment of Bladder Cancer

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01520038
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 for patients with pure or mixed variant urothelial carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma of the Bladder	Radiation: Proton therapy; Radiation: IMRT	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility and Phase 1/II Trial of Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton Therapy or IMRT
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [withion 14 days of estimated date of treatment completion]

   Applies to Proton only

2. Number of Participants With Adverse Events [within 90 days of radiation therapy]

   Applies to Both Proton and IMRT

Secondary Outcome Measures

1. Number of Participants With Adverse Events [later than 90 days from start of radiation therapy]

   Late toxicty

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: John Christodouleas, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01520038
• Other Study ID Numbers: UPCC 19811
• First Posted: Jan 27, 2012
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

Participant Flow

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Period Title: Overall Study
STARTED	2
COMPLETED	1
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 50%
>=65 years	1 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.3 (12.16)
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Applies to Proton only
Time Frame	withion 14 days of estimated date of treatment completion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Measure Participants	2
Count of Participants [Participants]	2 100%

2. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Applies to Both Proton and IMRT
Time Frame	within 90 days of radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Measure Participants	2
Count of Participants [Participants]	2 100%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
Measure Participants	2
Count of Participants [Participants]	2 100%

Adverse Events

Arm/Group Title	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
Arm/Group Description	Adjuvant Radiation Therapy for the Treatment of Urothelial Bladder Cancer Using Proton therapy or IMRT
All Cause Mortality
	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
	Affected / at Risk (%)	# Events
Total	1/2 (50%)
Serious Adverse Events
	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
General disorders
Death NOS	1/2 (50%)	1
Investigations
Lymphocyte count decreased	1/2 (50%)	1
Other (Not Including Serious) Adverse Events
	Adjuvant Radiation Therapy for the Treatment of Urothelial Bla
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Blood and lymphatic system disorders
Anemia	2/2 (100%)	4
Gastrointestinal disorders
Abdominal distension	1/2 (50%)	1
Abdominal pain	2/2 (100%)	3
Bloating	1/2 (50%)	1
Constipation	1/2 (50%)	1
Diarrhea	2/2 (100%)	2
Fecal incontinence	1/2 (50%)	1
Rectal pain	1/2 (50%)	1
General disorders
Fatigue	2/2 (100%)	4
Injury, poisoning and procedural complications
Dermatitis radiation	1/2 (50%)	1
Investigations
Creatinine increased	1/2 (50%)	1
Lymphocyte count decreased	2/2 (100%)	2
Weight loss	1/2 (50%)	1
Metabolism and nutrition disorders
Hypoalbuminemia	2/2 (100%)	2
Hypocalcemia	1/2 (50%)	1
Psychiatric disorders
Depression	2/2 (100%)	2
Reproductive system and breast disorders
Vaginal discharge	1/2 (50%)	1
Vaginal hemorrhage	1/2 (50%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea	1/2 (50%)	1
Nasal congestion	1/2 (50%)	1
Sore throat	1/2 (50%)	1
Skin and subcutaneous tissue disorders
Pruritus	1/2 (50%)	1
Vascular disorders
Hot flashes	1/2 (50%)	1
Hypertension	2/2 (100%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.