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Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00946543
First received: July 24, 2009
Last updated: August 23, 2013
Last verified: July 2009

July 24, 2009
August 23, 2013
March 2000
March 2010   (final data collection date for primary outcome measure)
Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00946543 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Local control [ Designated as safety issue: No ]
  • PSA control [ Designated as safety issue: No ]
  • Acute side effects as assessed weekly by the RTOG scoring system [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Patterns of recurrence [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer
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

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with 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.

Interventional
Phase 1
Primary Purpose: Treatment
Prostate Cancer
  • Radiation: hypofractionated radiation therapy
  • Radiation: intensity-modulated radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
198
Not Provided
March 2010   (final data collection date for primary outcome measure)

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)
Male
Not Provided
No
United Kingdom
 
NCT00946543
CDR0000601695, RMNHS-1766, EU-20869
Not Provided
Not Provided
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: David P. Dearnaley, MD, FRCP, FRCR Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP