Radiation Therapy in Treating Patients With Prostate Cancer
3 de dezembro de 2013 atualizado por: Medical Research Council
A Randomised Trial of High Dose Therapy in Localised Cancer of the Prostate Using Conformal Radiotherapy Techniques
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy.
- Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens.
- Compare the acute and late radiation-induced side effects of these regimens in this patient population.
- Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms.
All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy.
- Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks.
- Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
800
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Preston, Reino Unido, PR2 9HT
- Royal Preston Hospital
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England
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Birmingham, England, Reino Unido, B15 2TT
- University of Birmingham
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Bristol, England, Reino Unido, BS2 8ED
- Bristol Haematology and Oncology Centre
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Bristol, England, Reino Unido, BS2 8BJ
- Bristol Royal Hospital for Children
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Derby, England, Reino Unido, DE1 2QY
- Derbyshire Royal Infirmary
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Leeds, England, Reino Unido, LS16 6QB
- Cookridge Hospital
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Leicester, England, Reino Unido, LE1 5WW
- University Hospitals of Leicester
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London, England, Reino Unido, WIT 3AA
- Middlesex Hospital- Meyerstein Institute
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Manchester, England, Reino Unido, M20 4BX
- Christie Hospital N.H.S. Trust
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Merseyside, England, Reino Unido, L63 4JY
- Clatterbridge Centre for Oncology NHS Trust
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Newcastle Upon Tyne, England, Reino Unido, NE4 6BE
- Newcastle General Hospital
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Northwood, England, Reino Unido, HA6 2RN
- Mount Vernon Hospital
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Norwich, England, Reino Unido, NR1 3SR
- Norfolk & Norwich Hospital
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Oxford, England, Reino Unido, 0X3 9DU
- Oxford Radcliffe Hospital
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Sutton, England, Reino Unido, SM2 5PT
- Royal Marsden Hospital
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Westcliff-On-Sea, England, Reino Unido
- Southend NHS Trust Hospital
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Scotland
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Edinburgh, Scotland, Reino Unido
- Royal Hospital for Sick Children
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Glasgow, Scotland, Reino Unido, G11 6NT
- Beatson Oncology Centre
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Cape Town, África do Sul, 7925
- Groote Schuur Hospital, Cape Town
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
- T1b-T3a, N0, M0 (stage II or III)
- Prostate-specific antigen at least 50 ng/mL
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- WHO 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 4,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 11 g/dL
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No significant past medical history that would preclude radical radiotherapy
- No condition that would preclude standard radiotherapy
- No hip prosthesis
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No prior androgen deprivation therapy
Radiotherapy:
- No prior pelvic radiotherapy
Surgery:
- No prior radical prostatectomy
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: David P. Dearnaley, MD, FRCP, FRCR, Royal Marsden NHS Foundation Trust
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Barnett GC, De Meerleer G, Gulliford SL, Sydes MR, Elliott RM, Dearnaley DP. The impact of clinical factors on the development of late radiation toxicity: results from the Medical Research Council RT01 trial (ISRCTN47772397). Clin Oncol (R Coll Radiol). 2011 Nov;23(9):613-24. doi: 10.1016/j.clon.2011.03.001. Epub 2011 Apr 5.
- South CP, Khoo VS, Naismith O, Norman A, Dearnaley DP. A comparison of treatment planning techniques used in two randomised UK external beam radiotherapy trials for localised prostate cancer. Clin Oncol (R Coll Radiol). 2008 Feb;20(1):15-21. doi: 10.1016/j.clon.2007.10.012. Epub 2007 Dec 3.
- van As N, South C, Naismith O, et al.: Radiotherapy planning in UK phase III trials of dose-escalated (MRC RT01) and high-dose hypofractionated radiotherapy (CHHIP) in prostate cancer. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-98, 2006.
- Mayles WP, Moore AR, Aird EG, Bidmead AM, Dearnaley DP, Griffiths SE, Warrington AP; RT01 collaborators. Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397). Radiother Oncol. 2004 Nov;73(2):199-207. doi: 10.1016/j.radonc.2004.08.017.
- Sydes MR, Stephens RJ, Moore AR, Aird EG, Bidmead AM, Fallowfield LJ, Graham J, Griffiths S, Mayles WP, McGuire A, Stanley S, Warrington AP, Dearnaley DP; RT01 collaborators. Implementing the UK Medical Research Council (MRC) RT01 trial (ISRCTN 47772397): methods and practicalities of a randomised controlled trial of conformal radiotherapy in men with localised prostate cancer. Radiother Oncol. 2004 Aug;72(2):199-211. doi: 10.1016/j.radonc.2004.04.007.
- Gulliford SL, Partridge M, Sydes MR, Webb S, Evans PM, Dearnaley DP. Parameters for the Lyman Kutcher Burman (LKB) model of Normal Tissue Complication Probability (NTCP) for specific rectal complications observed in clinical practise. Radiother Oncol. 2012 Mar;102(3):347-51. doi: 10.1016/j.radonc.2011.10.022. Epub 2011 Nov 25.
- Gulliford SL, Foo K, Morgan RC, Aird EG, Bidmead AM, Critchley H, Evans PM, Gianolini S, Mayles WP, Moore AR, Sanchez-Nieto B, Partridge M, Sydes MR, Webb S, Dearnaley DP. Dose-volume constraints to reduce rectal side effects from prostate radiotherapy: evidence from MRC RT01 Trial ISRCTN 47772397. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):747-54. doi: 10.1016/j.ijrobp.2009.02.025. Epub 2009 Jun 18.
- Syndikus I, Morgan RC, Sydes MR, Graham JD, Dearnaley DP; MRC RT01 collaborators. Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397). Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):773-83. doi: 10.1016/j.ijrobp.2009.05.052. Epub 2009 Oct 14.
- Stanley S, Griffiths S, Sydes MR, Moore AR, Syndikus I, Dearnaley DP; RT01 Radiographer Trial Implementation Group. Accuracy and reproducibility of conformal radiotherapy using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Clin Oncol (R Coll Radiol). 2008 Oct;20(8):582-90. doi: 10.1016/j.clon.2008.04.019. Epub 2008 Jun 18.
- Dearnaley DP, Sydes MR, Graham JD, Aird EG, Bottomley D, Cowan RA, Huddart RA, Jose CC, Matthews JH, Millar J, Moore AR, Morgan RC, Russell JM, Scrase CD, Stephens RJ, Syndikus I, Parmar MK; RT01 collaborators. Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial. Lancet Oncol. 2007 Jun;8(6):475-87. doi: 10.1016/S1470-2045(07)70143-2.
- Dearnaley DP, Sydes MR, Langley RE, Graham JD, Huddart RA, Syndikus I, Matthews JH, Scrase CD, Jose CC, Logue J, Stephens RJ; RT01 Collaborators. The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397). Radiother Oncol. 2007 Apr;83(1):31-41. doi: 10.1016/j.radonc.2007.02.014. Epub 2007 Mar 27.
- Mangar SA, Sydes MR, Tucker HL, Coffey J, Sohaib SA, Gianolini S, Webb S, Khoo VS; MRC RT01 Trial Management Group; Dearnaley DP. Evaluating the relationship between erectile dysfunction and dose received by the penile bulb: using data from a randomised controlled trial of conformal radiotherapy in prostate cancer (MRC RT01, ISRCTN47772397). Radiother Oncol. 2006 Sep;80(3):355-62. doi: 10.1016/j.radonc.2006.07.037. Epub 2006 Sep 1.
- Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
- Stephen M, Helen T, Matthew S, et al.: Evaluating the relationship between erectile dysfunction and dose received by the penile bulb in patients undergoing conformal radiotherapy for prostate cancer: analysis of data from the MRC RT01 dose escalation trial (ISRCTN47772397). [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-209, S126, 2005.
- Stephens RJ, Cowan R, Dearnaley DP, et al.: The effect of hormone therapy on the quality of life of men with locally advanced prostate cancer (based on data from the MRC RT01 randomised trial (ISRCTN 47772397)). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1665, 414, 2003.
- Seddon B, Bidmead M, Wilson J, Khoo V, Dearnaley D. Target volume definition in conformal radiotherapy for prostate cancer: quality assurance in the MRC RT-01 trial. Radiother Oncol. 2000 Jul;56(1):73-83. doi: 10.1016/s0167-8140(00)00191-2.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 1998
Conclusão do estudo (Real)
1 de agosto de 2004
Datas de inscrição no estudo
Enviado pela primeira vez
1 de novembro de 1999
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de abril de 2003
Primeira postagem (Estimativa)
23 de abril de 2003
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de dezembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de dezembro de 2013
Última verificação
1 de julho de 2001
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CDR0000066222
- MRC-RT01
- EU-98005
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