A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer
OBJECTIVES:
- To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy
to the prostate and pelvic nodes of patients with prostate cancer.
- To determine the optimal dose level of this treatment regimen to be used in future
studies.
OUTLINE: Patients are stratified according to small bowel total volume (low small bowel
volume < 450 cc vs high small bowel volume ≥ 450 cc).
Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and
pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 5 years and
then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer meeting 1 of the following criteria:
- Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases
- Localized disease (stage pT2-T4) with > 30% estimated risk of pelvic nodal
metastases
- High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease
according to the National Collaborative Cancer Network (NCCN)
- Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive
high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node
involvement
- Candidate for radical radiotherapy
PATIENT CHARACTERISTICS:
- No inflammatory bowel disease or other small bowel disease
PRIOR CONCURRENT THERAPY:
- No prior pelvic radiotherapy or surgery (excluding prostatectomy)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter
Safety Issue:
Yes
Principal Investigator
David P. Dearnaley, MD, FRCP, FRCR
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
Unspecified
Study ID:
CDR0000601695
NCT ID:
NCT00946543
Start Date:
March 2000
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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