Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer (TOMOGYN)
Phase III Study Comparing 3D Conformal Radiotherapy and Conformal Radiotherapy IMRT to Treat Endometrial Cancer of 70 Years Old Women : Contribution of Oncogeriatric Evaluation to the Study of Acute Toxicity
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Endometrial cancer is the most common form of gynecological cancer in France with 6560 new cases in 2010. Endometrial cancers occurs generally after menopause but are sometimes diagnosticated before 40 years. The 5 years Overall survival of endometrial cancer is 76% (95% for non locally advanced or non metastatic disease).
Some factors are involved in disease prognostic: age, geographical origin, physical status, tumor grade, tumor histology and probably biomarkers. Some studies demonstrated that advanced age is a negative prognostic factor due to higher relapse risk and higher specific mortality. Unfortunately, Incidence of endometrial cancer will probably increase in future due to aging of the occidental population.
Current treatment of endometrial cancer is based on post-operative radiation therapy: adjuvant brachytherapy or adjuvant external beam radiation therapy. However these techniques lead to serious toxicity (digestive toxicity, ileitis...) in elder patient. Consequently, pelvic radiation therapy is difficult to organize before 75 years and dangerous to perform after 80 years.
However a new technique called: Intensity-modulated radiation therapy (IMRT) can make the difference. IMRT is a new high precision radiotherapy technique probably well adapted for old people, with less toxicity than current radiotherapy.
Nevertheless, IMRT is not recognized as a standard radiation therapy procedure in France and Europe.
Thus, goal of TOMOGYN study is to compare the tolerance of old women (at least 70 years), with endometrial cancer, treated with external beam radiation therapy or IMRT.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Bordeaux, França, 33076
- Bergonié Institut
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Caen, França, 14076
- François Baclesse Center
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Lille, França, 59020
- Oscar Lambret Center
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Lyon, França, 69373
- Centre Léon Bérard
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Reims, França, 51726
- Institut Jean Godinot
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Saint Herblain, França, 44805
- René Gauducheau Center
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Strasbourg, França, 67065
- Paul Strauss Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- endometrial adenocarcinoma histologically proven
- post op pelvic radiotherapy
- age ≥ 70
- performance status ≤ 2
- MMSE ≥ 10
- life expectancy ≥ 3 months
- social security covered
- signed informed consent
Exclusion Criteria:
- type I stade IAGI and stade IAGIII without myometer infiltration, stade IIIc2 and IV adenocarcinoma
- uterine sarcoma
- surgery not in accordance with recommendations of Inca
- previous uncontrolled or less than 5 years prior to diagnosis cancer
- cons-indication for radiotherapy
- diarrhea ≥ 3 per day
- pelvic lymph nodes > 1cm not resected during staging
- previous sigmoid diverticulitis, crohn disease, systemic disease, ulcerative haemorrhagic, collagenosis, infectious peritonitis
- IMRT other than tomotherapy
- photon energy < 10MV
- patient under guardianship
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 3D conformational radiotherapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
3D conformational radiation
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25 * 1.8 Gy in 5 weeks (=45 Gy)
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Experimental: Intensity-Modulated Radiation Therapy
25 * 1.8 Gy in 5 weeks (=45 Gy).
IMRT
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25 * 1.8 Gy in 5 weeks (=45 Gy)
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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change from baseline in acute toxicity all along the radiation
Prazo: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
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NCI CTCAE v 4.0 tox > grade 2 will be compared
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baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 Week after end of treatment, 8 Weeks after end of treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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geriatric intervention
Prazo: up to 6 months
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number of intervention, consequences in terms of base treatment change, intervention of other specialists (except cancer)
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up to 6 months
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geriatric repercussion
Prazo: baseline, 6 months after end of treatment
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scales : Activities in Daily Living (ADL), Instrumental Activities in Daily Living (IADL), Mini Nutritionnal Assessment (MNA), Geriatric Depression Scale (GDS), cognitive evaluation, Cumulative Illness RAting Scale-Geriatrics (CIRS-G), sociocultural questionnaire, walking and balance
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baseline, 6 months after end of treatment
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duration of the radiation
Prazo: up to 5 weeks and a half
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interval between first day and last day of treatment
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up to 5 weeks and a half
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quality of life
Prazo: baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment
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QLQ C30 questionnaire
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baseline, Day 5, Day 10, Day 15, Day 20, Day 25, 1 week and 8 weeks after end of treatment, 6, 12, 18 and 24 months after end of treatment
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late major toxicity
Prazo: 1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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NCI CTCAE v 4.0
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1 week, 8 weeks, 6, 12, 18 and 24 months after the end of treatment
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progression free survival
Prazo: an average period of 2 years
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median time between date of inclusion and date of clinical or radialogical progression
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an average period of 2 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Le Tinier Florence, MD, Centre Oscar Lambret
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TOMOGYN - 1105
- 2011-A01543-38 (Outro identificador: DEDIM (ANSM))
Plano para dados de participantes individuais (IPD)
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