Phase I/II Hypofractionated Radiotherapy for Prostate Cancer
NCT ID: NCT00214097
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
347 participants
INTERVENTIONAL
2002-10-14
2017-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Per protocol, while waiting for safety data to mature for escalation, protocol permitted enrollment to continue on last dose that was already proven safe. Thus Arms one and two have more than 50 subjects each.
TREATMENT
NONE
Study Groups
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Level 1
64.7 Gy/22 fractions of 2.94 Gy
Radiotherapy
Daily radiation to prescribed dose
Level 2
58.08 Gy/16 fractions of 3.63 Gy
Radiotherapy
Daily radiation to prescribed dose
Level 3
51.6 Gy/12 fractions of 4.3 Gy
Radiotherapy
Daily radiation to prescribed dose
Interventions
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Radiotherapy
Daily radiation to prescribed dose
Eligibility Criteria
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Inclusion Criteria
* Stage ≤ T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
* Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
* Gleason score ≤ 7
* No evidence of distant metastasis
* Age 18+
* Informed consent signed in accordance with institutional protocol
* Pretreatment evaluations must be completed as specified in Section 7.0.
* ECOG performance status 0-1
* No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
* No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
* No previous or concurrent cytotoxic chemotherapy
* No radical surgery or cryosurgery for prostate cancer
* The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
* The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
* No current use of anticoagulation therapy, other than aspirin.
18 Years
MALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Mark Ritter, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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References
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Brower JV, Forman JD, Kupelian PA, Petereit DG, Gondi V, Lawton CA, Anger N, Saha S, Chappell R, Ritter MA. Quality of life outcomes from a dose-per-fraction escalation trial of hypofractionation in prostate cancer. Radiother Oncol. 2016 Jan;118(1):99-104. doi: 10.1016/j.radonc.2015.12.018. Epub 2016 Jan 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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University of Wisconsin Carbone Cancer Center
Other Identifiers
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NCI (P01 CA88960)
Identifier Type: -
Identifier Source: secondary_id
2002-322
Identifier Type: OTHER
Identifier Source: secondary_id
A533300
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/HUMAN ONCOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
RO02803
Identifier Type: -
Identifier Source: org_study_id
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