NCT00450203|UnknownPhase 2DMC

Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer

ST03

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 Adenocarcinomas and (in Selected Centres) MRI and PET/CT Sub-studies

Professor David Cunningham ClinicalTrials.gov

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6 other identifiers

CDR0000536013MRC-ST03EU-20710ISRCTN460209482006-000811-1200316/0221/001

Study Type

interventional

Target

1,103

Locations

1 country

Sites

Timeline

RegisteredMar 2007

StartedOct 2007

CompletionDec 2017

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cisplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, and small molecule tyrosine kinase inhibitors, such as lapatinib, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Lapatinib targets a specific growth receptor, HER-2. Chemotherapy together with bevacizumab or lapatinib, in HER-2 positive tumours, may kill more tumor cells. PURPOSE: This randomized phase II/III trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works compared with combination chemotherapy alone in treating patients with previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study is studying the safety of adding lapatinib to chemotherapy in patients with HER-2 positive previously untreated stomach cancer, gastroesophageal junction cancer or lower oesophageal cancer that can be removed by surgery. The feasibility study will also assess the feasibility of timely HER-2 testing and estimate the HER-2 positivity rate in this patient population.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,103

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach

1 country

41 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.2 years study duration

First Submitted

Initial submission to the registry

March 20, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed

6 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed

10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

10.2 years

First QC Date

March 20, 2007

Last Update Submit

November 30, 2016

Conditions

Oesophagogastric Cancer

Keywords

adenocarcinoma of the stomachadenocarcinoma of the gastro oesophageal junctionadenocarcinoma of the lower oesophagus

Outcome Measures

Primary Outcomes (3)

Safety
at the end of phase II and phase III
Efficacy
end of trial
Overall survival
end of trial

Secondary Outcomes (9)

Feasibility
end of trial
Treatment-related morbidity
end of trial
Response rates to pre-operative treatment
at phase II review and at end of trial
Surgical resection rates
end of trial
Disease-free survival
end of trial
+4 more secondary outcomes

Study Arms (3)

ECX + Bevacizumab

EXPERIMENTAL

ECX + Bevacizumab

Biological: bevacizumabDrug: capecitabineDrug: cisplatinDrug: EpirubicinProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapy

Epirubicin, Cisplatin and Capecitabine

ACTIVE COMPARATOR

ECX chemotherapy

Drug: capecitabineDrug: cisplatinDrug: EpirubicinProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapy

ECX + Lapatinib

EXPERIMENTAL

ECX + Lapatinib

Drug: capecitabineDrug: cisplatinDrug: EpirubicinProcedure: adjuvant therapyProcedure: conventional surgeryProcedure: neoadjuvant therapyDrug: Lapatinib

Interventions

bevacizumabBIOLOGICAL

7.5mg/kg IV Day 1 of each 21 cycle of chemotherapy (6 cycles) plus day 1 of each maintenance dose every 21 days for 6 doses.

ECX + Bevacizumab

capecitabineDRUG

dose banded as based on patient BSA. Oral dose given twice a day during each 21 day cycle of chemotherapy (6 cycles in total)