A Randomised Phase II/III trial of peri-operative Chemotherapy with or without Bevacizumab in Operable Oesophagogastric Adenocarcinoma and A Feasibility Study Evaluating Lapatinib in HER-2 Positive Oesophagogastric Adenocarcinoma and (in selected centres) MRI and FDG-PET/CT Sub-studies - ST03

Medical Research Council Clinical Trials Unit0 sites1,100 target enrollmentJanuary 7, 2007

ConditionsPatients with histologically verfied lower oesophageal, Siewert Type I, II or III oesophagogastric junction or gastric adenocarcinoma.Type III or gastric tumours should be stage 1b (T1N1, T2a/bN0), II,III or stage IV (T4 N1orN2 M0). Lower oesophageal, Type I and II tumours should be stage II to stage IVa (T1N1, T2N1, T3N0-1, but not T2N0). T4 tumours are eligible if they involve the crura or invade the mediatinal pleural only.The tumour should be operable MedDRA version: 18.0Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsAvastin Tyverb

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with histologically verfied lower oesophageal, Siewert Type I, II or III oesophagogastric junction or gastric adenocarcinoma.Type III or gastric tumours should be stage 1b (T1N1, T2a/bN0), II,III or stage IV (T4 N1orN2 M0). Lower oesophageal, Type I and II tumours should be stage II to stage IVa (T1N1, T2N1, T3N0-1, but not T2N0). T4 tumours are eligible if they involve the crura or invade the mediatinal pleural only.The tumour should be operable
Sponsor: Medical Research Council Clinical Trials Unit
Enrollment: 1100
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 7, 2007

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Medical Research Council Clinical Trials Unit

Eligibility Criteria

Inclusion Criteria

•1\. a) Siewert type III OGJ or Gastric Adenocarcinomas (using gastric cancer staging system)
•Tumours should be Stage Ib (T1 N1, T2a/b N0\), II, III or stage IV (T4 N1 or N2\) with no evidence of distant metastases (M0\) where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure.
•Patients with linitis plastica should not be randomised.
•b) Lower Oesophageal or Siewert type I/II OGJ Adenocarcinomas (using oesophageal cancer staging system)
•Tumours should be Stage II to Stage IVa (T1 N1, T2 N1, T3 N0\-1, but not T2N0\). T4 (N0 or N1\) tumours are also eligible providing that they involve only the crura OR invade only the mediastinal pleura, where the surgeon believes that an R0 resection can be achieved by excision of a contiguous structure.
•Patients with nodal disease affecting the origin of the left gastric and splenic artery or coeliac axis (hitherto staged as M1a) are also eligible.
•2\. All patients should have a CT of chest and abdomen (pelvis is optional) prior to study entry. Patients with gastric and Siewert type II and III OGJ adenocarcinomas should also have a laparoscopy prior to study entry. Endoscopic ultrasound (EUS) should be performed for all lower oesophageal and OGJ adenocarcinomas and according to local practice for other tumours.
•3\. WHO performance status of 0 or 1\.
•4\. Adequate respiratory function: FEV1 greater than 1\.5 litres (mandatory for all lower oesophageal and junctional tumours only)
•5\. Adequate cardiac ejection fraction greater than or equal to 50% for ECHO or greater than or equal to LLN for MUGA, BP less than or equal to 140/90mmHg.