Intensity-Modulated Radiation Therapy in Treating Patients With Localized Prostate Cancer
NCT ID: NCT00392535
Last Updated: 2019-02-27
Study Results
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Basic Information
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UNKNOWN
NA
3216 participants
INTERVENTIONAL
2002-10-18
2021-06-17
Brief Summary
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PURPOSE: This randomized phase III trial is studying the side effects of three schedules of intensity-modulated radiation therapy and compares how well they work in treating patients with localized prostate cancer.
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Detailed Description
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* Determine the safety and efficacy of conventional vs hypofractionated high-dose intensity-modulated radiotherapy in patients with localized prostate cancer.
* Determine the side effects of these regimens in these patients.
* Determine whether hypofractionated radiotherapy schedules will improve the therapeutic ratio by either improving tumor control or reducing normal tissue side effects.
* Compare acute and late treatment-related gastrointestinal and urological toxicity in these patients.
* Determine different prostate-specific antigen-related endpoints for local failure and distant metastases.
* Extend the database of patients treated to escalated doses with dose-volume histograms (DVHs) of normal tissues at risk and relate these to common toxicity endpoints.
* Develop a model to estimate normal tissue complication probability (NTCP) of rectum and bladder for hypofractionated as well as conventional dose-escalated radiotherapy schedules.
OUTLINE: This is a multicenter, randomized, pilot study. Patients are stratified according to risk of seminal vesicle involvement (low-risk vs moderate-risk or high-risk).
* Hormone therapy: Patients receive androgen-deprivation therapy comprising an injection of luteinizing hormone-releasing hormone (LHRH) agonist once monthly for 3-6 months and oral cyproterone acetate beginning the week before the first LHRH agonist injection and continuing for at least 2 weeks after each LHRH agonist injection. Within one week after the last LHRH agonist injection, patients proceed to radiotherapy.
* Radiotherapy: Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients undergo conventional high-dose intensity-modulated radiotherapy (IMRT) in 37 fractions over 7.5 weeks.
* Arm II: Patients undergo hypofractionated high-dose IMRT in 20 fractions over 4 weeks.
* Arm III: Patients undergo hypofractionated high-dose IMRT in 19 fractions over 3.8 weeks.
In all arms, treatment continues in the absence of unacceptable toxicity.
Quality of life is assessed periodically during study treatment.
After completion of study treatment, patients are followed periodically for up to 15 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,163 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Control arm
conventional radiotherapy (74 Gy delivered in 37 fractions over 7·4 weeks)
conventional radiotherapy 74 Gy delivered in 37 fractions
Hypofractionated arm 1
Hypofractionated radiotherapy (60 Gy in 20 fractions over 4 weeks)
hypofractionated radiation therapy 60 Gy in 20 fractions
Hypofractionated arm 2
Hypofractionated radiotherapy (57 Gy in 19 fractions over 3·8 weeks)
hypofractionated radiation therapy 57 Gy in 19 fractions
Interventions
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conventional radiotherapy 74 Gy delivered in 37 fractions
hypofractionated radiation therapy 60 Gy in 20 fractions
hypofractionated radiation therapy 57 Gy in 19 fractions
Eligibility Criteria
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Inclusion Criteria
* WHO performance status 0 or 1
* Life expectancy \> 10 years (5 years for patients with poorly differentiated cancers)
* WBC \> 4,000/mm\^3
* Hemoglobin \> 11g/dL
* Platelet count \> 100,000/mm\^3
* No other active malignancy within the past 5 years except basal cell carcinoma
* No hip prosthesis or fixation that would interfere with standard radiation beam configuration
* No comorbid conditions likely to impact on the advisability of radical radiotherapy (e.g., previous inflammatory bowel disease, previous colorectal surgery, significant bladder instability, or urinary incontinence)
PRIOR CONCURRENT THERAPY:
* No prior pelvic radiotherapy
* No prior radical prostatectomy
* No prior androgen-deprivation therapy
* No concurrent full anticoagulation therapy with warfarin or heparin
18 Years
120 Years
MALE
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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David P. Dearnaley, FRCR
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
West Suffolk Hospital
Bury St Edmunds, England, United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom
Countess of Chester Hospital
Chester, England, United Kingdom
Walsgrave Hospital
Coventry, England, United Kingdom
Eastbourne District General Hospital
Eastbourne, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Clatterbridge Centre for Oncology
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Whiston Hospital
Prescot, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom
Halton Hospital
Runcorn, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Southport and Formby District General Hospital
Southport, England, United Kingdom
Royal Marsden - Surrey
Sutton, England, United Kingdom
Warrington Hospital NHS Trust
Warrington, England, United Kingdom
Worthing Hospital
Worthing, England, United Kingdom
Belfast City Hospital Trust
Belfast, Northern Ireland, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
Countries
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References
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Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, Graham J, Kirkbride P, Logue J, Malik Z, Money-Kyrle J, O'Sullivan JM, Panades M, Parker C, Patterson H, Scrase C, Staffurth J, Stockdale A, Tremlett J, Bidmead M, Mayles H, Naismith O, South C, Gao A, Cruickshank C, Hassan S, Pugh J, Griffin C, Hall E; CHHiP Investigators. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-1060. doi: 10.1016/S1470-2045(16)30102-4. Epub 2016 Jun 20.
Related Links
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ISRCTN registry
Other Identifiers
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ICR-CTSU-CHHIP-2006-10007
Identifier Type: -
Identifier Source: secondary_id
ISRCTN97182923
Identifier Type: -
Identifier Source: secondary_id
EU-20646
Identifier Type: -
Identifier Source: secondary_id
CDR0000510112
Identifier Type: -
Identifier Source: org_study_id
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