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- Ensayo clínico NCT07584161
MH-ART vs CF-IMRT in Postoperative Cervical/Endometrial Cancer (ARTISAN)
A Multicenter, Non-Inferiority, Phase III Randomized Controlled Trial Comparing Moderately Hypofractionated Online Adaptive Radiotherapy(MH-ART) vs. Conventional Fractionated Intensity-Modulated Radiotherapy(CF-IMRT) in Postoperative Cervical Cancer and Endometrial Cancer
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Randomization:
Intervention Group: Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
Control Group: Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
Stratification Factors for Randomization:Participating study center; Disease type (Cervical cancer / Endometrial cancer); Receipt of concurrent chemotherapy
Study Objectives:
Primary Endpoint: Acute adverse reactions/toxicity Secondary Endpoints: Late adverse reactions/toxicity, 3-year local control rate, 3-year distant metastasis rate, 3-year progression-free survival (PFS), 3-year overall survival (OS), 3-year disease-free survival (DFS), quality of life, cost-effectiveness analysis related to treatment.
Study Population:
Planned Sample Size: 228 participants
Inclusion Criteria:
- Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
- Age ≥18 years and ≤75 years.
- ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
- Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy).
- For participants with cervical cancer, the following criteria must be met:
(1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.
(2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.
Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.
6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1.
Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).
7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.
Study Duration: September 2025 to September 2030 Participant Involvement Period: Follow-up for over 3 years after radiotherapy
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xiaorong Hou, Professor
- Número de teléfono: +86 18612672203
- Correo electrónico: houxr@pumch.cn
Copia de seguridad de contactos de estudio
- Nombre: Zihan Yan
- Número de teléfono: +86 17860628938
- Correo electrónico: yanzihan_zora@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100730
- Reclutamiento
- Peking Union Medical College Hospital
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Contacto:
- Xiaorong Hou, Professor
- Número de teléfono: +86 18612672203
- Correo electrónico: houxr@pumch.cn
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Contacto:
- Zihan Yan
- Número de teléfono: +86 17860628938
- Correo electrónico: yanzihan_zora@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
- Age ≥18 years and ≤75 years.
- ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
- Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy).
- For participants with cervical cancer, the following criteria must be met:
(1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.
(2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.
Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.
6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1.
Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).
7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.
8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.
9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.
Exclusion Criteria:
- Presence of confirmed distant metastasis or para-aortic lymph node metastasis;
- Requirement for extended-field radiotherapy encompassing the para-aortic region;
- Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered;
- History of previous abdominal or pelvic radiotherapy;
- History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast);
- History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;
- Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types;
- Pregnant or lactating women;
- Presence of active infection or fever;
- Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: MH-ART
Moderately fractionated radiotherapy using online adaptive radiotherapy technology.
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Treatment will be delivered using an online adaptive radiotherapy device.
A moderately fractionated regimen will be employed, with a prescribed dose of 40.05 Gy in 15 fractions, administered once daily, five times per week.
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Otro: CF-IMRT
Conventionally fractionated radiotherapy using image-guided intensity-modulated radiotherapy technology.
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Intensity-modulated radiotherapy techniques will be used, including FF-IMRT, VMAT, or TOMO.
A conventionally fractionated regimen will be employed, with a prescribed dose of 45 Gy in 25 fractions, administered once daily, five times per week.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Acute Toxicity
Periodo de tiempo: Within 90 days (inclusive) from the start of radiotherapy
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Toxicities occurring within 90 days (inclusive) from the start of radiotherapy are defined as acute toxicities.
Acute toxicities will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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Within 90 days (inclusive) from the start of radiotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Late Toxicity
Periodo de tiempo: From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.
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Toxicities occurring more than 90 days after the start of radiotherapy are defined as late toxicities.
Late toxicities will be evaluated using the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
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From 90 days after the start of radiotherapy until death from any cause, assessed up to 3 years.
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3 years Local Recurrence Rate
Periodo de tiempo: From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.
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The proportion of subjects who do not experience tumor recurrence or progression within the radiation field within 3 years after the end of radiotherapy.
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From the end of radiotherapy until local recurrence or death from any cause, assessed up to 3 years.
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3 years Distant Metastasis Rate
Periodo de tiempo: From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.
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The proportion of subjects who develop distant metastasis within 3 years after the start of radiotherapy.
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From the start of radiotherapy until distant metastasis or death from any cause, assessed up to 3 years.
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3 years Progression-Free Survival
Periodo de tiempo: From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.
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The time interval from the start of radiotherapy to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause within 3 years after the start of radiotherapy.
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From the start of radiotherapy until the first disease recurrence (local/regional/distant) or death from any cause, assessed up to 3 years.
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3 years Overall Survival
Periodo de tiempo: From the start of radiotherapy until death from any cause, assessed up to 3 years.
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The time interval from the start of radiotherapy to death from any cause within 3 years after the start of radiotherapy.
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From the start of radiotherapy until death from any cause, assessed up to 3 years.
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3 years Disease-Free Survival
Periodo de tiempo: From the start of radiotherapy until the first local/regional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.
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The time interval from the start of radiotherapy to the first occurrence of local or regional recurrence, distant metastasis, or death from any cause within 3 years after the start of radiotherapy.
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From the start of radiotherapy until the first local/regional recurrence, distant metastasis, or death from any cause, assessed up to 3 years.
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Quality of Life
Periodo de tiempo: Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.
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Quality of life will be assessed using the QLQ-C30 questionnaire, in combination with the disease-specific module (QLQ-CX24 for cervical cancer; QLQ-EN24 for endometrial cancer).
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Baseline, at the end of radiotherapy, and every 3 months thereafter until 3 years from start of radiotherapy.
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Treatment-Related Cost-Effectiveness Analysis
Periodo de tiempo: From the start of radiotherapy until death from any cause, assessed up to 3 years.
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The cost assessment should cover both medical costs and non-medical costs.
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From the start of radiotherapy until death from any cause, assessed up to 3 years.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias Genitales Femeninas
- Enfermedades del cuello uterino
- Neoplasias Uterinas
- Neoplasias del cuello uterino
- Neoplasias Endometriales
Otros números de identificación del estudio
- ARTISAN
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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