A Study of the Combination of Oxaliplatin, Capecitabine and Herceptin (Trastuzumab) and Chemoradiotherapy in The Adjuvant Setting in Operated Patients With HER2+ Gastric or Gastro-Esophageal Junction Cancer (TOXAG Study)
Conditions
Gastric Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Oxaliplatin Type: Drug
Name: Radiation Type: Radiation
Name: capecitabine Type: Drug
Name: trastuzumab [Herceptin] Type: Drug
Overall Status
Recruiting
Summary
This single arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine and Herceptin (trastuzumab) and chemoradiotherapy in the adjuvant setting in patients with curatively resected HER2-positive gastric or gastro-esophageal junction cancer. Patients will receive Herceptin 8 mg/kg intravenously (iv) on Day 1 of Cycle 1 and 6 mg/kg iv on Day 1 of every following 3-week cycle, with oxaliplatin 100 mg/m2 iv on Day 1 of Cycles 1-3 and capecitabine 850 mg/m2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 Gy divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Locations
Adana, Turkey
Status: Recruiting
Ankara, Turkey
Status: Recruiting
Ankara, Turkey
Status: Terminated
Ankara, Turkey
Status: Recruiting
Gaziantep, Turkey
Status: Recruiting
Istanbul, Turkey
Status: Recruiting
Izmir, Turkey
Status: Recruiting
Konya, Turkey
Status: Recruiting
Sıhhiye, ANKARA, Turkey
Status: Recruiting
Start Date
January 2013
Completion Date
June 2017
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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