A trial comparing chemotherapy and bevacizumab or lapatinib with chemotherapy alone for cancer of the stomach, oesophagus or the junction of the stomach and oesophagus

Phase 1

• 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; 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]

• Registration Number: EUCTR2006-000811-12-GB
• Lead Sponsor: Medical Research Council Clinical Trials Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-07
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

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.

6. Adequate bone marrow, Liver and renal function

7. 24 hr Urine collection for protein uria < 1g

8. Adequate coagulation profile

9. Patient fit to receive protocol treatment

10. Patients aged over 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

1. Cereborvascular disease

2. Cardiovascular Diseses including:
-myocardial Infarction (less than 1 year prior to randomisation)
- uncontrolled hypertension (BP>140/90mmHg)
- angina requiring nitrate therapy within 1 year prior to randomisation
- New York Heart Association Grade II or greater
- Serious cardiac arrhythmia requiring medication

3. Major Surgery/Trauma or biopsy within 28 days prior to randomisation

4. Serious non-healing wound, ulcer or bone fracture

5. Evidence of bleeding diathesis or coagulopathy

6. Recent history of any gastric inflammatory condition

7. Patient's with severe tinnitus

8. Patient's who have received chemotherapy or radiotherapy treatment previously

9. Lack of physical intergrity of the upper GI tract.

10. Positive serology for HIV, Hep C or active Hep B.

11. Patients who have previously received anthracycline treatment

12. known peripheral neuropathy (grade 1 and greater).

13. DPD deficiency

14. Allergy to chinese hamster ovary cell proteins or other recombinant human or humanized antibodies or to any exicpients of bevacizumab formulation, platinum compounds or to any other components of the study drugs.

15. Patients with oesophageal or gastric stent (metal or biodegradable) in situ.

16. Patients with a history of interstitial lung disease or radiological evidence of lung fibrosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified