A randomised phase II/III trial of peri-operative chemotherapy with or without bevacizumab in operable adenocarcinoma of the stomach and gastro-oesophageal junction

Medical Research Council (UK)0 sites1,100 target enrollmentJanuary 25, 2007

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cancer of the stomach and gastro-oesophageal junction adenocarcinoma
Sponsor: Medical Research Council (UK)
Enrollment: 1100
Status: Completed
Last Updated: 5 years ago

Registry

who.int

Start Date

January 25, 2007

End Date

October 31, 2012

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Medical Research Council (UK)

•1\. Patients with histologically verified gastric or type III gastro\-oesophageal junction adenocarcinoma, who have not received any treatment for their cancer
•2\. Tumours should be stage 1b (T1 N1\), II, III with no evidence of distant metastases or stage IV considered to be T4, N1 or N2, M0 where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure. All patients should have a laparoscopy and a Computed Tomography (CT) of chest and abdomen (pelvis is optional) prior to study entry. Endoscopic UltraSound (EUS) should be performed for all type III gastro\-oesophageal junctional tumours and according to local practice for other tumours
•Assessments to be performed within four weeks prior to randomisation:
•1\. World Health Organisation (WHO) performance status zero or one
•2\. Adequate respiratory function: Forced Expiratory Volume in one second (FEV1\) more than 1\.5 litres
•3\. Adequate cardiac ejection fraction more than 50% (as determined by MUltiple Gated Acquisition scan \[MUGA] or Echocardiogram \[ECHO])
•Assessments to be performed within one week prior to randomisation:
•1\. Adequate bone marrow function:
•1\.1\. Absolute Neutrophil Count (ANC) more than 1\.5 litres
•1\.2\. white blood cell count more than 3 x 10^9/l

•Significant co\-existing or previous medical conditions:
•1\. Cerebrovascular disease (including Transient Ischaemic Attacks \[TIA] and strokes) within a year before trial entry
•2\. Cardiovascular diseases as follows:
•2\.1\. Myocardial infarction (less than one year prior to randomisation)
•2\.2\. Uncontrolled hypertension while receiving chronic medication
•2\.3\. Unstable angina
•2\.4\. New York Heart Association (NYHA) grade II or greater congestive heart failure
•2\.5\. Serious cardiac arrhythmia requiring medication
•3\. Major surgery, major trauma or open biopsy within 28 days prior to study entry
•4\. Serious non\-healing wound, ulcer or bone fracture