Adjuvant Proton Therapy or IMRT for the Treatment of Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01520038
First received: January 25, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Urothelial Carcinoma of the Bladder
Radiation: Proton therapy
Radiation: IMRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: withion 14 days of estimated date of treatment completion ] [ Designated as safety issue: Yes ]
    Applies to Proton only

  • Acute Toxicity [ Time Frame: within 90 days of radiation therapy ] [ Designated as safety issue: Yes ]
    Applies to Both Proton and IMRT


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: later than 90 days from start of radiation therapy ] [ Designated as safety issue: Yes ]
    Late toxicty


Estimated Enrollment: 30
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520038

Locations
United States, Pennsylvania
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
  More Information

No publications provided

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01520038     History of Changes
Other Study ID Numbers: UPCC 19811
Study First Received: January 25, 2012
Last Updated: April 4, 2014
Health Authority: United State: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on April 17, 2014