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
Recruitment status was Recruiting
Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00946543
First received: July 24, 2009
Last updated: February 18, 2011
Last verified: July 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 198 |
| Study Start Date: | March 2000 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946543
Locations
| United Kingdom | |
| Institute of Cancer Research - Chelsea | Recruiting |
| London, England, United Kingdom, SW3 6JB | |
| Contact: Contact Person 44-20-7352-8133 | |
| Institute of Cancer Research - Sutton | Recruiting |
| Sutton, England, United Kingdom, SM2 5NG | |
| Contact: Contact Person 44-181-643-8901 | |
| Royal Marsden - Surrey | Recruiting |
| Sutton, England, United Kingdom, SM2 5PT | |
| Contact: David P. Dearnaley, MD, FRCP, FRCR 44-20-8661-3271 | |
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
| Principal Investigator: | David P. Dearnaley, MD, FRCP, FRCR | Royal Marsden NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00946543 History of Changes |
| Other Study ID Numbers: | CDR0000601695, RMNHS-1766, EU-20869 |
| Study First Received: | July 24, 2009 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013