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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)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Turkey: Ministry of Health Turkish Medicine and Medical Device Organization

Study ID:

ML25574

NCT ID:

NCT01748773

Start Date:

January 2013

Completion Date:

June 2016

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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