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Trial record 1 of 1 for:    NCT02316548
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Surgery With or Without Postoperative Intensity Modulated Radiation Therapy in Treating Patients With Urothelial Bladder Cancer

This study has been terminated.
(Trial will not meet CTEP Early Phase Trial Slow Accrual Guidelines)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02316548
First Posted: December 15, 2014
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology
  Purpose
This randomized phase II trial studies the side effects and how well postoperative intensity modulated radiotherapy works after surgery in treating patients with urothelial bladder cancer. Radiation therapy uses high energy x-rays to kill tumor cells left behind in the pelvis after surgery. It is not yet known whether surgery followed by radiotherapy is more effective than surgery alone in treating patients with urothelial bladder cancer.

Condition Intervention
Stage III Bladder Cancer Stage IV Bladder Cancer Other: No radiation Radiation: Intensity-Modulated Radiation Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Postoperative Adjuvant IMRT Following Cystectomy for pT3/T4 Urothelial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by NRG Oncology:

Primary Outcome Measures:
  • Pelvic recurrence-free survival (PRFS) [ Time Frame: From randomization to 12 months ]
    PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This will be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy. Biopsy is not required.


Secondary Outcome Measures:
  • Disease free survival (DFS) [ Time Frame: Up to 10 years ]
    Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death

  • Incidence of acute radiation bowel toxicity, scored using the Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 [ Time Frame: From of the start of radiotherapy up to 90 days ]
    Bowel toxicity will be evaluated using the CTCAE version 4.0

  • Incidence of late radiation bowel toxicity, scored using the CTCAE v4.0 [ Time Frame: From 91 days from the start of radiotherapy up to 10 years ]
    Bowel toxicity will be evaluated using the CTCAE version 4.0


Enrollment: 14
Actual Study Start Date: February 2015
Study Completion Date: February 1, 2017
Primary Completion Date: February 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (No radiation)
Patients do not receive radiation.
Other: No radiation
No radiation is received by the patient.
Experimental: Arm II (Post-op Adjuvant IMRT)
Patients receive Intensity-Modulated Radiation Therapy (IMRT).
Radiation: Intensity-Modulated Radiation Therapy
Undergo radiotherapy (IMRT)
Other Name: IMRT

Detailed Description:

PRIMARY OBJECTIVE:

I. To evaluate the ability of postcystectomy adjuvant radiotherapy to safely reduce pelvic tumor recurrence, defined as pelvic recurrence-free survival.

SECONDARY OBJECTIVES:

I. Evaluate increase in disease-free survival. II. Evaluate toxicity of adjuvant pelvic radiotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients are stratified by neoadjuvant preoperative or postoperative adjuvant chemotherapy.

ARM I: No radiotherapy.

ARM II: Patients undergo radiotherapy (IMRT) 1.8 Gy, 5 days a week over 6 weeks for a total of 28 treatments and 50.4 Gy, in the absence of disease progression or unacceptable toxicity. IMRT starts within 14 days of registration if no postoperative adjuvant chemotherapy, otherwise within 14 days of the completion of the chemotherapy.

After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Initial histological diagnosis of muscle invasive urothelial carcinoma within 180 days prior to registration
  • Patients must have undergone a radical cystectomy with ileal conduit for urothelial bladder carcinoma within 49 days prior to registration; final cystectomy pathology must be either pure urothelial carcinoma or dominant urothelial carcinoma with admixture of other histologies excluding small cell variants

    • Neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy for the bladder cancer is permitted; however, all patients who will receive adjuvant chemotherapy must be registered within 49 days after completing cystectomy regardless of whether adjuvant chemotherapy has started. Patients who will be receiving adjuvant (postoperative) chemotherapy will be randomized within 21 days of completing chemotherapy
  • Patients with the following TNM stages are eligible:

    • pT3apN0; pN1; pN2 provided less than 10 nodes dissected and/or positive surgical margins
    • pT3bpN0; pN1; pN2
    • pT4apN0; pN1; pN2
    • pT4bpN0; pN1; pN2
  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination =< 45 days prior to registration;
    • Computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)-CT that includes the chest, abdomen and pelvis should be performed for initial radiological staging. This may be performed pre- or post-surgery =< 90 days prior to registration except in patients getting postoperative adjuvant chemotherapy, who will require CT, MRI or PET-CT including the chest and abdomen and pelvis no more than 30 days prior to registration; imaging performed postoperatively should show no evidence of residual disease
  • Age >=18
  • Zubrod performance status 0-2 =< 45 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin >= 8.0 g/dl (NOTE: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
  • The patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease; pN3 disease is not allowed
  • Any type of orthotopic neobladder creation (new bladder placed in same location as the old bladder)
  • Prior invasive solid tumor or hematological malignancy (except non-melanomatous skin cancer and incidentally discovered prostate cancer at time of cystoprostatectomy) unless disease free for a minimum of 3 years
  • Prior chemotherapy for other malignancy; neoadjuvant pre-cystectomy chemotherapy is permitted
  • Prior radiotherapy to the pelvis
  • Patients with a history of inflammatory bowel disease
  • Patients who have required any treatment (medical or surgical) for bowel obstruction prior to diagnosis of bladder cancer or who have required surgical treatment for bowel obstruction after the cystectomy
  • Severe, active co-morbidity defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
    • Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol
    • Other major medical illness which requires hospitalization or precludes study therapy at the time of registration
  • Women who are breast feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316548


  Show 101 Study Locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Libni Eapen NRG Oncology
  More Information

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT02316548     History of Changes
Other Study ID Numbers: NRG-GU001
NCI-2014-02061 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GU001 ( Other Identifier: NRG Oncology )
NRG-GU001 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Submitted: December 10, 2014
First Posted: December 15, 2014
Last Update Posted: February 6, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases