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Total Neoadjuvant Treatment vs. Chemoradiotherapy in Local Advanced Rectal Cancer With High Risk Factors (TNTCRT)

4 de mayo de 2018 actualizado por: Ziqiang Wang,MD, West China Hospital

Total Neoadjuvant Treatment Versus Conventional Neo-chemoradiotherapy in Locally Advanced Rectal Cancer With High Risk Factors: a Multicenter Randomized Phase III Clinical Study.

Purpose:To compare the efficacy and the safety of total neoadjuvant chemotherapy + TME with standard neoadjuvant concurrent chemoradiotherapy + TME + adjuvant chemotherapy for locally advanced rectal cancer patients with high risk factors of recurrence.

Evaluation indexes: (1) the primary evaluation index: disease-free survival (disease free survival, DFS); (2) the secondary evaluation indexes: pathological complete remission rate (pCR), the 3 year overall survival (overall survival, OS); R0 dissection rate; distant metastasis free survival (DMFS); local recurrence free survival rate (LRRFS); tumor regression grade (TRG, tumor regression grade) and the adverse reaction rate during the chemotherapy, the operation safety index; quality of life; psychological and cognitive effects, assessment of nutritional status.

Safety evaluation indexes: including all adverse events observed during the experiment.

Number of patients: 458 cases Study design: patients will be randomly assigned into the total neoadjuvant treatment group (experimental group, TNT) and neoadjuvant concurrent chemotherapy group (control group, CRT) in the ratio of 1: 1. The patients of experimental group will be given 1 cycle of induction CAPOX (Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2, bid, d1-14) prior to radiotherapy. Then pelvic IMRT/VMAT (50-50.4Gy/25-28f) and two cycles of concurrent chemotherapy (Oxaliplatin 130mg/m2, d1, d 22, Capecitabine 825mg/m2, bid, 5d/w, 25-28d) are performed. And three cycles of consolidation chemotherapy (CAPOX) are delivered after concurrent chemoradiotherapy. Total mesorectal excision (TME) is performed after completion of the whole neoadjuvant treatment. The patients of control group will receive standard concurrent neoadjuvant chemoradiotherapy with capecitabine (825mg/m2, bid, 5d/w) followed by TME 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients are treated with another 6 cycles of CAPOX.

Schedule: Investigators plan to finish the study in 4 years and write the related work within 2 years after the completion of this study.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

458

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ziqiang Wang
  • Número de teléfono: +86 28 85422480
  • Correo electrónico: wangzqzyh@163.com

Copia de seguridad de contactos de estudio

  • Nombre: Xin Wang
  • Número de teléfono: +86 28 85423609
  • Correo electrónico: wangxin213@sina.com

Ubicaciones de estudio

    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • Reclutamiento
        • West China Hospital
        • Contacto:
          • Ziqiang Wang, MD
    • Zhejiang
      • Hanzhou, Zhejiang, Porcelana, 310009
        • Aún no reclutando
        • The Second Affiliated Hospital of Zhejiang University
        • Contacto:
          • Kefeng Ding, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:(1)Age: 18 ~ 70 years old; sex is not limited. (2)Patients with stage II/III rectal cancer staged under MRI or endoscopic ultrasonography and have at least one risk factor: cT4a-b(resectable);cT3c-d with EMVI+ (Extramural venous invasion);cN2;MRF+ (MRI in evaluating the mesorectal fascia).(According to the 2010 AJCC cancer staging system, the seventh edition). The preoperative T stage is referred to endoscopic ultrasonography or rectal MRI. The N stage is referred to abdominal CT. The M stage is referred to abdominal and thoracic CT. If symptoms occur, other appropriate imaging examinations are needed(cranial MRI or ECT).

(3)The lower edge of lesion is less than 12cm from anal verge according to rigid sigmoidoscopy or rectal digital examination.

(4)No distant metastasis after a thorough examination . (5)Pathological diagnosis of rectal adenocarcinoma. (6)ECOG score: 0-1. (7)Patients with primary rectal cancer who had not received surgery prior to surgery (except for palliative ileostomy or colostomy), radiotherapy, systemic chemotherapy or other anti-tumor therapy.

(8)The main organ function is normal, including the following characteristics:

  • Blood routine examination: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L,PLT≥ 100×109/L

    • Biochemical examination:Crea and BIL ≤ 1.0 upper normal limit(ULN),ALT and AST≤ 2.5 upper normal limit(ULN).

      (9)Not allergic to 5-Fu or Platinum. (10)The site of radiotherapy had not previously received radiation. (11)If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment. If female and of childbearing potential, or if male, agree to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method) based on the judgment of the investigator or a designated associate from the date on which the ICF (Informed Consent Form) is signed until 8 weeks after the last dose of study drug.

      (12)Participants are volunteered to participate in this study, sign informed consent, good compliance, cooperation with follow-up.

Exclusion Criteria:(1)Have had prior or concurrent cancer distinct in primary site or histology EXCEPT for curatively treated cervical cancer in situ, Basal cell carcinoma of skin.

(2)Pregnant or lactating women. (3)Patients with severe cardiovascular disease and poorly controlled diabetes. (4)Mental disorder. (5)Severe infection. (6)Patients who can't finish MRI examination. (7)Patients were treated with thrombolytic therapy and anticoagulant therapy, either with bleeding diathesis or coagulopathy, or aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year.

(8)The past history of kidney disease, urine or urine protein found in clinical renal abnormalities.

(9)The digestive tract fistula, perforation or serious ulcer disease. (10)Be allergic to 5-Fu or Platinum. (11)The presence of severe gastrointestinal diseases that affecting the absorption of oral chemotherapy drugs.

(12)Additional clinical trials were attended within 4 weeks before treatment initiation.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Total neoadjuvant treatment
The interventions of experimental group include 1 cycle of CAPOX before radiotherapy; and then start concurrent chemoradiotherapy with CAPOX regimen (capecitabine: 825mg/m2, bid, 5d/w; oxaliplatin, 130mg/m2, D1, q3w) for 2 cycles followed by 3 cycles of CAPOX 2-3 weeks after the completion of radiotherapy. Intensity modulated radiotherapy (IMRT/VMAT) was used for radiotherapy, and the dose was 50-50.4Gy/25-28f, 1.8-2.0Gy/d, 5f/w. The TME operation will be given 3-4 weeks after the end of the total neoadjuvant treatment.
The interventions of experimental group include 1 cycle of CAPOX before radiotherapy; and then start concurrent chemoradiotherapy with CAPOX regimen (capecitabine: 825mg/m2, bid, 5d/w; oxaliplatin, 130mg/m2, D1, q3w) for 2 cycles followed by 3 cycles of CAPOX 2-3 weeks after the completion of radiotherapy. Intensity modulated radiotherapy (IMRT/VMAT) was used for radiotherapy, and the dose was 50-50.4Gy/25-28f, 1.8-2.0Gy/d, 5f/w.
Otros nombres:
  • TNT
The TME operation will be given after the end of the neoadjuvant treatment.
Comparador activo: concurrent chemoradiotherapy group
The interventions of control group is standard preoperative concurrent chemoradiotherapy. The radiotherapy target areas and dosage are the same as group TNT. During radiotherapy, only oral capecitabine will be delivered and capecitabine dose was 825mg/m2, bid, 5d/w. The TME surgery will be performed 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients will receive another 6 cycles of CAPOX.
The TME operation will be given after the end of the neoadjuvant treatment.
The interventions of control group is standard preoperative concurrent chemoradiotherapy. The radiotherapy target areas and dosage are the same as group TNT. During radiotherapy, only oral capecitabine will be delivered and capecitabine dose was 825mg/m2, bid, 5d/w. The TME surgery will be performed 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients will receive another 6 cycles of CAPOX.
Otros nombres:
  • Tubo de rayos catódicos
Patients will receive another 6 cycles of CAPOX after TME.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
disease free survival
Periodo de tiempo: 3 years
Time from the completion of the treatment to any recurrences or distant metastases
3 years

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pathological complete remission rate
Periodo de tiempo: 1 months
The rate of complete remission patients to all resected patients
1 months
the 3 year overall survival rate
Periodo de tiempo: 3 years
The rate of patients alive 3 years after the completion of treatment
3 years
R0 dissection rate
Periodo de tiempo: 1 months
The rate of patients who received R0 dissection to all the patients
1 months
distant metastasis free survival
Periodo de tiempo: 3 years
Time from the completion of the treatment to any distant metastases
3 years
local recurrence free survival rate
Periodo de tiempo: 3 years
The rate of patients without local recurrence to all the patients
3 years
tumor regression grade (TRG)
Periodo de tiempo: 1 months
The level of tumor regression under pathological examination
1 months
the adverse effects during the chemotherapy
Periodo de tiempo: 3 months
Any side effects during the chemotherapy
3 months
the operation safety index
Periodo de tiempo: 3 months
The safety index of operation
3 months
quality of life
Periodo de tiempo: 3 years
Patients' subjective feeling of life
3 years
psychological and cognitive effects
Periodo de tiempo: 3 years
The psychological and cognitive changes of patients after treatment
3 years
assessment of nutritional status
Periodo de tiempo: 6 months
The nutritional status of patients
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de junio de 2017

Finalización primaria (Anticipado)

30 de mayo de 2021

Finalización del estudio (Anticipado)

30 de mayo de 2023

Fechas de registro del estudio

Enviado por primera vez

31 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2017

Publicado por primera vez (Actual)

6 de junio de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

4 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Total neoadjuvant treatment

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