Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer (ADAPT-EC)
Adaptive Daily MR-Guided Adjuvant Pelvic Therapy-Endometrial Cancer: A Phase I/II Feasibility Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this research study is to evaluate a new way of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment. If you take part in the research, you will receive radiation therapy using MR-guided imaging. This involves daily radiation treatments that may be adjusted based on imaging taken at each session (called adaptive radiotherapy). This approach is considered investigational because it is not yet a standard treatment for endometrial cancer. Your time in the research will take Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments due to the imaging and treatment planning performed on the same day.The purpose of this research study is to evaluate a new method of delivering radiation therapy for patients with endometrial cancer. This study will test a shorter course of radiation treatment using magnetic resonance (MR)-guided technology, which allows for more precise targeting of the treatment areas. The goal is to determine whether this approach is safe, well-tolerated, and effective, while potentially reducing side effects and the overall time required for treatment.
If you participate in this research, you will receive radiation therapy guided by MR imaging. This will involve daily radiation treatments that may be adjusted based on imaging taken at each session (known as adaptive radiotherapy). This approach is considered investigational as it is not yet a standard treatment for endometrial cancer.
Your participation in the study will involve approximately 15 treatment sessions over about 3 weeks. Each session may take longer than standard radiation treatments because imaging and treatment planning are performed on the same day.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lara Hathout, MD
- Número de telefone: 732-235-2465
- E-mail: Lh547@rutgers.edu
Locais de estudo
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers Cancer Institut Jersey
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Contato:
- Lara Hathout
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Histologically confirmed endometrial carcinoma (endometrioid, serous, clear cell, carcinosarcoma, or dedifferentiated histology).
- Indication for adjuvant pelvic radiotherapy (± vaginal brachytherapy) for HIR defined by the ASTRO guidelines and GOG-99(7, 9) :
- Age
- High-grade histology (grade 2-3)
- Depth of myometrial invasion
- LVSI
- Positive pelvic nodes
- Cervical stromal invasion
- Presence of poor prognostic molecular markers
- Age ≥18 years.
- Ability to provide informed consent.
- Eligible to receive adjuvant systemic therapy, if indicated, with a minimum 3-week interval between chemotherapy and radiotherapy.
- Willing and able to complete EORTC QLQ-C30 and EN-24 questionnaires in a validated language version.
Exclusion Criteria:
- Prior pelvic radiotherapy.
- Contraindication to pelvic radiotherapy (e.g., active connective tissue disorder or inflammatory bowel disease).
Presence of a hip prosthesis that would compromise treatment planning or delivery.
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Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Experimental: MR-guided Adaptive Pelvic IMRT
Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
Vaginal brachytherapy may be administered following IMRT at the treating physician's discretion per institutional standards.
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Participants receive moderately hypofractionated MR-guided adaptive pelvic intensity-modulated radiation therapy (IMRT) delivered via MR-linac to a total dose of 42 Gy in 15 fractions with daily onboard MRI guidance and online adaptive replanning as needed to optimize target coverage and minimize radiation exposure to surrounding organs at risk.
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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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Incidence of Acute Grade ≥2 Gastrointestinal and Genitourinary Toxicity
Prazo: Within 90 days after completion of treatment
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Defined as the number and proportion of participants experiencing grade ≥2 acute gastrointestinal or genitourinary treatment-related adverse events occurring within 90 days after completion of MR-guided adaptive pelvic IMRT, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, a standardized grading system for adverse events ranging from Grade 1 (mild) to Grade 5 (death related to adverse event)
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Within 90 days after completion of treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient-Reported Quality of Life
Prazo: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Assessed using the EORTC QLQ-C30 to evaluate quality of life and symptom burden over time.
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Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Patient Reported Quality of Life
Prazo: Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Description: Assessed using the EN-24 questionnaire to evaluate quality of life and symptom burden over time.
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Time Frame: Baseline, end of treatment, 3 months, 6 months, 12 months, then every 6-12 months up to 2 years
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Disease-Free Survival
Prazo: Up to 2 years after completion of treatment.
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Disease-free survival will be measured as the time from completion of MR-guided adaptive pelvic IMRT to the first documented recurrence or death from any cause, whichever occurs first.
Recurrence will be assessed by clinical evaluation and/or imaging according to institutional standards.
Participants without recurrence or death will be censored at the date of last disease assessment.
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Up to 2 years after completion of treatment.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lara M Hathout, Rutgers University - Cancer Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 152601
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