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 currently recruiting participants.
Verified March 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01748773
First received: December 10, 2012
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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: trastuzumab [Herceptin] Drug: Oxaliplatin Drug: capecitabine Radiation: Radiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Combination therapy |
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
Drug: Oxaliplatin
100 mg/m2 iv on Day 1, 3 cycles
Drug: capecitabine
850 mg/m2 orally bid, Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 </= 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748773
Contacts
| Contact: Please reference Study ID Number: ML25574 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Turkey | |
| Baskent University Practice and Research Hospital; Medical Oncology | Recruiting |
| Adana, Turkey, 01220 | |
| Hacettepe University Medical Faculty Hospital; Oncology Department | Recruiting |
| Ankara, Turkey, 06230 | |
| Ankara Oncology Hospital; Oncology | Recruiting |
| Ankara, Turkey, 06200 | |
| Ankara Numune Hospital; Onkoloji | Recruiting |
| Ankara, Turkey, 06100 | |
| Gaziantep University Medical Faculty; Medical Oncology Department | Recruiting |
| Gaziantep, Turkey, 27310 | |
| Marmara University Faculty of Medicine; Medical Oncology | Recruiting |
| Istanbul, Turkey, 34662 | |
| Ege University Medical Faculty; Oncology Department | Recruiting |
| Izmir, Turkey, 35100 | |
| Necmettin Erbakan University Meram Medical Faculty; Internal Diseases | Recruiting |
| Konya, Turkey, 42080 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01748773 History of Changes |
| Other Study ID Numbers: | ML25574 |
| Study First Received: | December 10, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Turkey: Ministry of Health Turkish Medicine and Medical Device Organization |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Trastuzumab Capecitabine |
Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013