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)

October 7, 2019 updated by: Hoffmann-La Roche

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]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01250
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Ankara, Turkey, 06200
        • Ankara Oncology Hospital; Oncology
      • Ankara, Turkey, 06100
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
      • Ankara, Turkey, 06490
        • Baskent University Medical Faculty; Internal Medicine
      • Gaziantep, Turkey, 27310
        • Gaziantep University Medical Faculty, Medical Oncology Department
      • Istanbul, Turkey, 34890
        • Marmara Uni Faculty of Medicine; Medical Oncology
      • Izmir, Turkey, 35100
        • Ege Uni Medical Faculty; Oncology Dept
      • Konya, Turkey, 42080
        • Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
      • Çankaya/Ankara, Turkey, 06800
        • Bilkent Sehir Hospita; ONKOLOJI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
Cycle 1 Day 1 up to death due to any reason (up to 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2013

Primary Completion (Actual)

August 21, 2015

Study Completion (Actual)

June 15, 2017

Study Registration Dates

First Submitted

December 10, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25574

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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