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Phase II trial to evaluate the combination of FOLFOX6 + Bevacizumab in initially unresectable liver metastases from colorectal cancer

ABSTRACT: Primary objectives: percentuale di pazienti che saranno sottoposti a resezione completa Primary endpoints: Lo Studio si propone di aumentare la percentuale di resecabilita’ di pazienti con metastasi epatiche da carcinoma del colon retto.

DISEASE(S): Colon Cancer Metastatic,Metasthatic Colon-rectum And Kidney Cancer

PROVIDER: 2517634 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Ensayo Clínico aleatorio y a doble cieo de eficacia analgésica postoperatoria en cirugía colo-rectal y cirugía hepática con infusión contínua de anestesico local verus suero salino en la incisión quirúrgica

Project description:Primary objectives: ? Determinar si el consumo de opiáceos en pacientes tratados con perfusión continua de anestésico local es inferior al consumo de pacientes tratados con perfusión contínua de suero fisiológico Primary endpoints: 1. Reacción adversa grave a alguno de los fármacos administrados, según criterio clínico.2. Retirada accidental u oclusión de los catéteres3. Infección de la herida quirúrgica. 4. Insuficiencia hepática (aumento de transaminasas, aumento de la bilirrubina y alargamiento del tiempo de protrombina) En caso de suspensión del estudio, la pauta analgésica a administrar estará constituida por: ? Cirugía de colon: Analgesia con PCA de Cloruro mórfico: bolus de 0,5mg, bloqueo de 5 min. i AINEs pautados? Cirugía hepática: Sistema de PCA : bolus 0,5 mg, bloqueo de 8 min i AINEs pautados.

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Study to assess the efficacy of the drug Cabazitaxel in patients with Metastatic Colorectal Cancer.

Project description:Primary objectives: Evaluar la eficacia de Cabazitaxel en pacientes con cáncer colorrectal metastásico resistente al tratamiento estándar. Primary endpoints: Evaluar la eficacia de Cabazitaxel mediante la estimación de la tasa de respuesta global (ORR), entendida como el porcentaje de individuos que alcanzan una respuesta tumoral completa (CR) o una respuesta tumoral parcial (PR) en cada brazo y a su vez comparándolos entre sí. Se llevarán a cabo evaluaciones del tumor hasta progresión o abandono del estudio. Para ello se utilizarán los criterios RECIST 1.1 cada 8 semanas.

| 2529387 | ecrin-mdr-crc

Estudio aleatorizado, multicéntrico, doble ciego, comparativo, exploratorio y controlado con placebo en fase II con FOLFIRI en combinación con MSC1936369B o placebo, con una "safety run-in part", como segunda linea de tratamiento en pacientes con cáncer colorrectal metastásico con k-ras mutadoA double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial o...

Project description:Primary objectives: Parte 1: SAFETY RUN-IN PART Determinar la Dosis Máxima Tolerada (DMT) y la Dosis Recomendada de Fase II (DRF2) de MSC1936369B combinado con FOLFIRI como tratamiento de segunda línea en pacientes con Cáncer colorrectal metastásico con K-Ras mutado (CCRm). Parte 2: PARTE DE ASIGNACIÓN ALEATORIZADA FASE II Valorar la actividad anti-tumoral de MSC1936369B combinado con FOLFIRI como tratamiento de segunda línea en pacientes con CCRm K-Ras mutado en términos de Supervivencia libre de progresión (SLP). Primary endpoints: Safety Run-in Part Toxicidad limitante de dosis (TLD) utilizando los Criterios Comunes de Terminología NCI para Acontecimientos Adversos v3.0 (CTCAE), evaluada durante el primer ciclo de tratamiento. Se utilizará el número y la incidencia de TLDs por nivel de dosis en el análisis estadístico primario de la Safety Run-in Part. Parte de Asignación Aleatorizada Fase II Tiempo de supervivencia libre de progresión (SLP), definido como el tiempo (en meses) desde la fecha de asignación aleatorizada hasta la primera progresión de la enfermedad según lo notificado y documentado por el investigador (ej., progresión radiológica por RECIST v1.0) o muerte por cualquier causa. Se censurará la SLP en el momento de posterior tratamiento antes de la progresión. En el análisis estadístico principal de la Parte de Asignación Aleatorizada Fase II se utilizará la Razón de Riesgo (RR) de la SLP del grupo experimental versus el grupo control.

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Estudio de fase II, abierto y multicéntrico para evaluar la eficacia y seguridad de la combinación de panitumumab con irinotecán en pacientes con cáncer colorrectal metastásico con KRAS no mutado y refractario a la quimioterapia basada en irinotecán.Open, multicenter phase II study to evaluate the efficacy and safety of the combination of Panitumumab with Irinotecan in patients with Wild-Type KRAS...

Project description:Primary objectives: Estimar el efecto de la combinación de panitumumab con irinotecán en la tasa de respuesta tumoral, definida como respuesta parcial y completa según los criterios RECIST modificados, en sujetos con CCRm con KRAS no mutado y refractario a la quimioterapia basada en irinotecán Primary endpoints: Tasa de respuesta objetiva (TRO) durante la fase de tratamiento con terapia combinada.

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Next Generation Sequencing (RNA-Sequencing) for the analysis of RUNX3 and YAP1 targets in TGFb-stimulated HEK 293 cells

Project description:Comparision of the gene expression profiles of the TGFb-stimulated and si-Con, si-RUNX3 and si-YAP1 treated cells.

2023-11-09 | GSE226590 | GEO

Efficacy of modified FOLFOX6 chemotherapy for patients with unresectable pseudomyxoma peritonei.

Project description:BackgroundPseudomyxoma peritonei (PMP) is a rare malignancy, and there is insufficient evidence about systemic chemotherapy for this disease.MethodsWe retrospectively evaluated the efficacy and safety of a chemotherapeutic regimen with 5-fluorouracil and oxaliplatin (modified FOLFOX6, mFOLFOX6) for patients with unresectable pseudomyxoma peritonei. Patients who received the therapy between April 2000 and February 2019 at the Department of Medical Oncology, Tohoku University Hospital, were enrolled in this study.ResultsEight patients were treated with mFOLFOX6. The sites of primary tumor were appendix in six patients, ovary in a patient, and urachus in a patient. Six patients received surgery. Seven patients had histologically high-grade PMP, and one patient had low-grade PMP. The median follow-up duration was 27.2 months. All the patients had non-measurable regions as the targets of tumor response. Non-complete response or non-progressive disease was observed in seven patients, with a disease control rate of 87.5%. The median progression-free survival and overall survival were 13.0 months and 27.9 months, respectively. An obvious reduction in the symptoms was observed in two patients. Five patients experienced decline in the serum tumor markers, CEA or CA19-9. The grade 3/4 toxicity that was observed was grade 4 neutropenia in one patient and grade 3 neutropenia in two patients.ConclusionsmFOLFOX6 might be an effective and tolerable treatment option for patients with unresectable PMP. To our knowledge, this is the first case series of mFOLFOX6 in patients with unresectable PMP and the first case series of systemic chemotherapy for Asian patients with unresectable PMP.

| S-EPMC7118031 | biostudies-literature

Conversion surgery for initially unresectable extrahepatic biliary tract cancer.

Project description:Backgrounds/aimsSurgical resection is the only curative treatment for biliary tract cancers; however, most patients undergo palliative chemotherapy because they are contraindicated for surgery. Conversion surgery, a treatment strategy for downsizing chemotherapy and subsequent surgical resection, is feasible for initially unresectable biliary tract cancers following the introduction of effective chemotherapeutic agents.MethodsPatients initially diagnosed with unresectable biliary tract cancers, and treated with conversion surgery after palliative chemotherapy between 2013 and 2019, were reviewed retrospectively.ResultsTwelve patients underwent conversion surgery after palliative chemotherapy for initially unresectable biliary tract cancers. The final pathological diagnosis included six perihilar cholangiocarcinomas, four distal common bile duct cancers, and two gallbladder cancers. Different chemotherapy regimens were used, but all the patients were treated with gemcitabine at some point during their treatment. The median overall survival was 28 months, which was longer than that of patients treated with isolated palliative chemotherapy in previous studies.ConclusionsConversion surgery represents a therapeutic alternative for specific cases of unresectable biliary tract cancers. Palliative chemotherapy for initially unresectable biliary tract cancers is recommended for downsizing the tumor and expanding the indications for surgery. Further studies and clinical trials are required to develop new and effective chemotherapeutic regimens.

| S-EPMC8382869 | biostudies-literature

An Phase 2 Clinical Trial of Panitumumab in Conbination vith Irinotecan chemotherapy as 2nd line Therapy in subjects with Metastatic Colorectal Cancer. Ensayo Clínico fase II de Panitumumab combinado con quimioterapia de Irinotecan como tratamiento de segunda linea en sujetos con cáncer colorectal metastásico.

Project description:Primary objectives: Evaluar la tasa de resuesta objetiva cuando se administra Panitumumab combinado con Irinotecan como tratmiento de segunda linea en sujetos con cancer colorectal matastásico (CCRm) Primary endpoints: Tasa de respuesta objetiva (TRO) durante la fase de tratamiento combinado.

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Efficacy of conversion therapy on initially unresectable locally advanced rectal cancer.

Project description:Background and purpose: Research on the efficacy of conversion therapy for initially unresectable mid-low rectal cancer (IURC) remained limited. This study aimed to assess the efficacy and safety of the conversion regimen for IURC and analyze the long-term outcomes of these patients. Methods: We retrospectively analyzed the data of clinically diagnosed IURC patients who received conversion therapy between October 2010 and April 2017. The conversion therapy consisted of long-term radiation, concurrent chemotherapy, delayed surgery and consolidation chemotherapy. The primary end point was the rate of R0 resection, and other short- and long-term outcomes were analyzed. Results: Sixty-one patients were enrolled in this study. After conversion therapy, 51 (83.6%) patients received R0 resection. The rates of pathologic complete response and downstaging were 16.4% and 62.3%, respectively. The rate of grade 3-4 chemoradiotherapy-related toxicity events was 13.1%. The overall survival at 3 years was 75.4% in all patients, and the disease-free survival at 3 years was 72.5% in patients who received R0 resection. Conclusion: The conversion regimen showed a high conversion resection rate and good survival outcomes in IURC patients, and might benefit the patients if recommended in clinical practice.

| S-EPMC8176423 | biostudies-literature

Proteoma de Centruroides bicolor de Panamá

Project description:datos de ms/ms del veneno de escorpión Centruroides bicolor de Panamá. archivos por duplicado de cortes con quimiotripsina y tripsina

2024-10-16 | PXD056837 |

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