NeoSCOPEA Randomised Phase II Study of Two Pre-operative Chemoradiotherapy Regimens (Oxaliplatin and Capecitabine Followed by Radiotherapy With Either Oxaliplatin and Capecitabine or Paclitaxel and Carboplatin) for Resectable Oesophageal Cancer
Oxaliplatin
+ Capecitabine
+ Carboplatin
Enfermedades del Sistema Digestivo+6
+ Neoplasias del sistema digestivo
+ Enfermedades del esófago
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 2013
Fecha en la que se inscribió al primer participante.About 7500 patients are diagnosed with oesophageal cancer each year in the UK of which less than a quarter have resectable disease at diagnosis. There is a general lack of consistency in the standard of care for patients across UK hospitals. Patients are either treated with a) chemotherapy followed by surgical removal of the tumour, or b) chemoradiotherapy followed by removal of the tumour by surgery, as part of their standard of care. Recent research supports the latter treatment, as chemoradiotherapy maybe more effective at shrinking the tumour and preventing the disease from spreading than taking chemotherapy alone. However, there is no definitive way of identifying which treatment is best without a clinical trial. Evidence suggests that the effect of the chemoradiotherapy currently used as standard practice may be improved and the side effects reduced by using a different chemoradiotherapy combination. In this trial, eligible patients will receive 2 cycles of the same chemotherapy before being randomised to receive two different chemoradiotherapy regimens (carboplatin and paclitaxel verses oxaliplatin and capecitabine) both of which have shown promising results in previous studies. Patients will then have their tumour removed. The best chemoradiotherapy regimen will then be taken forward to a Phase III trial in which chemoradiotherapy will be compared with chemotherapy alone. The efficacy of the regimens will be measured by counting the number of patients who i) remain free from cancer, ii)have local or distant spread of their cancer, iii) are successfully recruited and iv) experience toxicities. A specific set of toxicity criteria will be used to monitor any treatment induced side-effects and provide justification for any necessary dose modifications or withdrawal of treatment.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 85 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Histologically confirmed operable oesophageal cancer (adenocarcinoma) Tumour must be staged as a T3, 4 or N1 (using TNM6 staging) or T3, T4a or N13 using TNM7 staging) Maximum disease (Tumour plus nodes) length 8 cm staged with EUS and CT/PET WHO performance status 01 Adequate haematological, renal, respiratory, cardiac and hepatic function The patient has provided written informed consent. Exclusion Criteria: Histologically confirmed operable oesophageal cancer (squamous cell carcinoma) Uncontrolled angina pectoris, myocardial infarction within 6 months, heart failure, clinically significant uncontrolled cardiac arrhythmias, or any patient with a clinically significant abnormal ECG. Patients with any previous treatment for oesophageal carcinoma. Siewert type 3 oesophagogastric tumours. T4 tumours invading contiguous structures other than diaphragm, crura or mediastinal pleura. Patients with disease in any of the following areas on the CT scan, EUS or other staging investigation: Evidence of metastases in liver, lung, bone or other distant metastases. Abdominal para aortic lymphadenopathy >1cm diameter on CT or >6mm diameter on EUS. Invasion of tracheo-bronchial tree, aorta, pericardium or lung. Lymphadenopathy encasing the coeliac axis (as described above, patients with single nodes lying anterior to the origin of the splenic artery and anterior to the origin of the coeliac axis are not excluded). Any patient with a single significant medical condition which is thought likely to compromise his or her ability to tolerate any of the above therapies. Specific contraindications to surgery, chemotherapeutic agents (including known allergies to chemotherapy) or radiotherapy. Pregnant or lactating women and fertile women who will not be using adequate contraception during the trial.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 12 ubicaciones
Bristol Oncology and Haematology Centre
Bristol, United KingdomAbrir Bristol Oncology and Haematology Centre en Google MapsValindre NHS
Cardiff, United KingdomUniversity Hospitals Coventry and Warwickshire
Coventry, United KingdomSt James's Hospital
Leeds, United Kingdom