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. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01748773
First received: December 10, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This single arm, open-label study will evaluate the safety and efficacy of the c ombination oxaliplatin, capecitabine and Herceptin (trastuzumab) and chemoradiot herapy in the adjuvant setting in patients with curatively resected HER2-positiv e 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 d ays per week during chemoradiotherapy. Radiotherapy will be given at a total dos e of 45 Gy divided into 25 doses on 5 treatment days each week for 5 weeks start ing 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
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: November 2015
Estimated Primary Completion Date: November 2015 (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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748773

Contacts
Contact: Reference Study ID Number: ML25574 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Turkey
Recruiting
Adana, Turkey, 01250
Not yet recruiting
Adapazar?, Turkey, 54100
Recruiting
Ankara, Turkey, 06490
Recruiting
Ankara, Turkey, 06100
Recruiting
Ankara, Turkey, 06200
Recruiting
Gaziantep, Turkey, 27310
Recruiting
Istanbul, Turkey, 34890
Recruiting
Izmir, Turkey, 35100
Recruiting
Konya, Turkey, 42080
Recruiting
S?hhiye, ANKARA, Turkey, 06100
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: August 26, 2014
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 August 28, 2014