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Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

20 de febrero de 2018 actualizado por: Beth Israel Medical Center

A Phase II Open-labeled, Prospective Study to Determine the Efficacy of Preoperative Chemoradiation With Oxaliplatin/5-FU in Locally Advanced Rectal Cancer Followed by Total Mesorectal Excision and FOLFOX6

RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer.

Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant

PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for rectal cancer.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

OBJECTIVES:

Primary

  • To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy.

Secondary

  • To observe the overall pathologic response rate in these patients.
  • To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
  • To assess toxic side effects of these regimens in these patients.
  • To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients.

OUTLINE:

Patients with stage II/III rectal cancer were treated with OXA 60mg/m2 weekly continuous infusion 5FU of 225 mg/m2/d d1-5 with pelvic RT of 1.8Gy/d for 28 doses. Adjuvant therapy consisted of 6 cycles of biweekly FOLFOX6.

Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.

Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Tipo de estudio

Intervencionista

Inscripción (Actual)

27

Fase

  • Fase 2

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.

Ubicaciones de estudio

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10019
        • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
      • New York, New York, Estados Unidos, 10003
        • Beth Israel Medical Center - Philipps Ambulatory Care Center

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria

  • Histologically proven adenocarcinoma of the rectum with no distant metastases.
  • T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT
  • The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.
  • No prior chemotherapy or pelvic irradiation.
  • ECOG performance status 0-1
  • Age 18 to 70 years
  • ANC >= 1500/mm3 and platelets >= 100,000/mm3
  • Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN

Exclusion Criteria

  • Pregnant or lactating females; patients not practicing active contraception while sexually active.
  • No other serious medical condition
  • A psychiatric disorder that would prohibit the subject from participating fully.
  • Peripheral neuropathy > grade 1
  • History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.
  • HIV positive patients

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Preoperative Chemoradiation
Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)
Droga: 5-FU
5-FU: continuous infusion via portable pump during all RT (approximately 33 days)
Otros nombres:
  • fluorouracilo
Droga: Oxaliplatin
Oxaliplatin: 50mg/m2 weekly dosing during RT (Day 1)
Otros nombres:
  • Eloxatina
Droga: leucovorin
Folinic Acid (Leucovorin): 400 mg/m2; 2-hour IV infusion simultaneously with oxaliplatin
Otros nombres:
  • Ácido folínico
Procedimiento: mesorectal excision
mesorectal excision

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pathologic Response and Complete Response
Periodo de tiempo: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months

Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation.

The unit of measure is the tumor response rate to preoperative chemoradiation.

Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer.

Tumor regression grade (TRG) will be quantitated into five grades:

TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall.

TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis.

TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant.

TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Treatment Toxicity
Periodo de tiempo: Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).
Toxicity was assessed weekly during neoadjuvant chemotherapy and radiation therapy, bi-weekly during adjuvant FOLFOX therapy.
Weekly during chemoradiation treatment (3 months). Bi-weekly during adjuvant FOLFOX therapy (3.5 months).
Complete Resectability Rates
Periodo de tiempo: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Complete resectability rates assessed by circumferential margin.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Local Regional Control
Periodo de tiempo: median follow-up 22 months post-TME
subjects were followed for median of 22 months post-surgery
median follow-up 22 months post-TME
Disease-free Survival
Periodo de tiempo: median 22 months follow-up
median 22 months follow-up
Overall Survival
Periodo de tiempo: median follow-up 22 months
median follow-up 22 months
Patterns of Disease Failure, Including Local Recurrence and Distant Metastasis Assessed by CT Scan
Periodo de tiempo: median follow-up 22 months
median follow-up 22 months
Number of Participants With Comparison of Preoperative Stage With Post-treatment Pathologic Stage
Periodo de tiempo: Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.
Thin-section high resolution pelvic MRI was used to image the tumor prior to chemoradiation and repeated prior to surgery, and then compared to post-treatment pathological stage.
Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, 3 months after beginning of chemoradiation treatment.

Colaboradores e Investigadores

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

Patrocinador

Beth Israel Medical Center

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

1 de julio de 2004

Finalización primaria (Actual)

1 de noviembre de 2009

Finalización del estudio (Actual)

1 de noviembre de 2009

Fechas de registro del estudio

Enviado por primera vez

27 de enero de 2009

Primero enviado que cumplió con los criterios de control de calidad

27 de enero de 2009

Publicado por primera vez (Estimar)

28 de enero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de marzo de 2018

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

20 de febrero de 2018

Última verificación

1 de febrero de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CDR0000633360
  • BIMCP-OX-08-006 (Identificador de registro: BIMCP-OX-08-006)
  • AVENTIS-BIMCP-OX-08-006 (Otro número de subvención/financiamiento: AVENTIS-BIMCP-OX-08-006)

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. .

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