Oesophagogastric Cancer Clinical Trial
Official title:
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
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.
OBJECTIVES:
Primary
- Assess the safety and efficacy of neoadjuvant and adjuvant chemotherapy comprising
epirubicin hydrochloride, cisplatin, and capecitabine with or without bevacizumab in
patients with previously untreated, resectable gastric, gastroesophageal junction or
lower oesophageal cancer.
- Assess the safety of neoadjuvant and adjuvant chemotherapy comprising epirubicin
hydrochloride, cisplatin, and capecitabine with or without lapatinib in patients with
HER-2 positive previously untreated, resectable gastric, gastroesophageal junction or
lower oesophageal cancer.
OUTLINE: This is a multicenter, randomized, open-label, controlled study. Patients are
randomized to 1 of 4 treatment arms.
- Arm I and II: Patients receive epirubicin hydrochloride IV and cisplatin IV over 4
hours on day 1 and capecitabine orally twice daily on days 1-21. Treatment repeats
every 21 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.
Patients undergo surgery 5-6 weeks after completion of chemotherapy. Patients then receive 3
additional courses of chemotherapy beginning 6-10 weeks after surgery.
- Arm II: Patients receive bevacizumab IV over 30-90 minutes, epirubicin hydrochloride
IV, and cisplatin IV over 4 hours on day 1 and capecitabine orally twice daily on days
1-21. Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
Patients undergo surgery 5-8 weeks after completion of chemotherapy. Patients then receive 3
additional courses of chemotherapy and bevacizumab beginning 6-10 weeks after surgery.
Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on
day 1. Maintenance therapy repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
- Arm IV: Patients receive lapatinib orally once daily, epirubicin hydrochloride IV, and
cisplatin IV over 4 hours on day 1 and capecitabine orally twice daily on days 1-21.
Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
Patients undergo surgery 5-8 weeks after completion of chemotherapy. Patients then receive 3
additional courses of chemotherapy and lapatinib beginning 6-10 weeks after surgery.
Patients then receive maintenance therapy comprising lapatinib orally once daily on days
1-21. Maintenance therapy repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, during treatment, and during the follow-up period.
After completion of study treatment, patients are followed at 9, 18, and 27 weeks after the
start of course 4, 1 year post surgery, every 6 months for 2 years, and then annually
thereafter.
PROJECTED ACCRUAL: A total of 1063 patients were recruited to the bevacizumab comparison of
the study (now closed to recruitment) and 40 patients with HER-2 positive tumours will be
recruited into the ST03 feasibility study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06057220 -
IMaC - Immune Pathways in Oesophagogastric Cancer
|