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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)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 10, 2012
Last updated: November 1, 2016
Last verified: November 2016
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.

Condition Intervention Phase
Gastric Cancer
Drug: Oxaliplatin
Radiation: Radiation
Drug: capecitabine
Drug: trastuzumab [Herceptin]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 4 years ]
  • Overall survival [ Time Frame: 4 years ]

Enrollment: 35
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination therapy Drug: Oxaliplatin
100 mg/m2 iv on Day 1, 3 cycles
Radiation: Radiation
Total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 22 (+/- 3 days) of Cycle 3
Drug: capecitabine
850 mg/m2 orally bid, Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy
Drug: trastuzumab [Herceptin]
8 mg/kg iv on Day 1 Cycle 1, 6 mg/kg iv on Day 1 of each following 3-week cycle, 12 months


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01748773

Adana, Turkey, 01250
Ankara, Turkey, 06100
Ankara, Turkey, 06200
Ankara, Turkey, 06490
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34890
Izmir, Turkey, 35100
Konya, Turkey, 42080
Sıhhiye, ANKARA, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01748773     History of Changes
Other Study ID Numbers: ML25574
Study First Received: December 10, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 22, 2017