Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Adjuvant Setting in Operated HER2+ Patients With Gastric or Gastroesophageal Junction Adenocarcinoma: A Phase II Study (TOXAG Study)
Inclusion Criteria:
- Adult patients, 18 to 75 years of age
- Curatively resected HER2-positive gastric or gastro-esophageal junction
adenocarcinoma; HER2+ status as defined by IHC2+ or IHC3+ with corroborative FISH+
result
- Patients with Stage IB (T1N1M0) disease or higher, except metastatic (Stage IV)
disease
- Eastern Cooperative Oncology Group (ECOG) performance status = 2
- Left ventricular ejection fraction >/= 50%
- No known contraindication to capecitabine, oxaliplatin or trastuzumab
- No contraindication for radiotherapy or has not received any previous radiotherapy
for any reason
Exclusion Criteria:
- Previous neoadjuvant chemotherapy and/or radiotherapy
- Any disruption in the physical integrity of the upper gastrointestinal tract (except
surgical intervention for gastric or gastro-esophageal junction carcinoma)
- Known (previously diagnosed and on-going) malabsorption syndrome
- Active gastrointestinal bleeding
- Any other malignancies within the past 5 years, except for squamous cell carcinoma of
the skin
- Clinically significant cardiac or cardiovascular disease
- Uncontrolled hypertension
- Patients who have received any investigational anti-cancer treatment or are being
treated in a concomitant investigational drug study