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A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer (TOXAG)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01748773
First received: December 10, 2012
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (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 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m^2 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 gray (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 plus a 1-year follow-up period.

Condition Intervention Phase
Gastric Cancer Gastroesophageal Junction Cancer Drug: Oxaliplatin Radiation: Radiation Drug: Capecitabine Drug: Trastuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 13 ]
  • Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score [ Time Frame: From Baseline to Month 13 ]

Secondary Outcome Measures:
  • Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months) ]
  • Overall Survival [ Time Frame: Cycle 1 Day 1 up to death due to any reason (up to 24 months) ]

Enrollment: 35
Actual Study Start Date: January 29, 2013
Estimated Study Completion Date: September 30, 2017
Primary Completion Date: August 21, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
Drug: Oxaliplatin
Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.
Radiation: Radiation
Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.
Drug: Capecitabine
Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
Drug: Trastuzumab
Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).

  Eligibility

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

Inclusion Criteria:

  • Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result
  • Participants with stages between Stage IB (T1N1M0) and Stage IIIC
  • ECOG performance status score equal to or less than (<=) 2 during screening
  • Left ventricular ejection fraction equal to or higher than (>=) 55% with acceptable levels of liver and renal functions
  • No known contraindication to capecitabine, oxaliplatin, and trastuzumab
  • No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason

Exclusion Criteria:

  • Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin
  • Previous neoadjuvant chemotherapy and/or radiotherapy
  • Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma)
  • Known (previously diagnosed and ongoing) malabsorption syndrome
  • Active gastrointestinal bleeding
  • Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma
  • Clinically significant cardiac or cardiovascular disease
  • Uncontrolled hypertension
  • Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study
  • Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin
  • Known or suspected hypersensitivity against trastuzumab or proteins of rodents
  • Pregnancy or lactation
  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

Locations
Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey, 01250
Ankara Numune Hospital; Onkoloji
Ankara, Turkey, 06100
Ankara Oncology Hospital; Oncology
Ankara, Turkey, 06200
Baskent University Medical Faculty; Internal Medicine
Ankara, Turkey, 06490
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, Turkey, 27310
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, Turkey, 34890
Ege Uni Medical Faculty; Oncology Dept
Izmir, Turkey, 35100
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
Konya, Turkey, 42080
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, ANKARA, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: June 19, 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 28, 2017