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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)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer

Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Oxaliplatin
Radiation
Capecitabine
Trastuzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Ankara Oncology Hospital; Oncology
  • Baskent University Medical Faculty; Internal Medicine
  • Gaziantep University Medical Faculty, Medical Oncology Department
  • Marmara Uni Faculty of Medicine; Medical Oncology
  • Ege Uni Medical Faculty; Oncology Dept
  • Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
  • Bilkent Sehir Hospita; ONKOLOJI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Therapy

Arm Description

Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

Secondary Outcome Measures

Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)
Overall Survival

Full Information

First Posted
December 10, 2012
Last Updated
October 7, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01748773
Brief Title
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
Acronym
TOXAG
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]
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2013 (Actual)
Primary Completion Date
August 21, 2015 (Actual)
Study Completion Date
June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Baseline up to Month 13
Title
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time Frame
From Baseline to Month 13
Secondary Outcome Measure Information:
Title
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)
Title
Overall Survival
Time Frame
Cycle 1 Day 1 up to death due to any reason (up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Oncology Hospital; Oncology
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Baskent University Medical Faculty; Internal Medicine
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Gaziantep University Medical Faculty, Medical Oncology Department
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Marmara Uni Faculty of Medicine; Medical Oncology
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Facility Name
Ege Uni Medical Faculty; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Bilkent Sehir Hospita; ONKOLOJI
City
Çankaya/Ankara
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33979100
Citation
Abali H, Yalcin S, Onal HC, Dane F, Oksuzoglu B, Ozdemir N, Mertsoylu H, Artac M, Camci C, Karabulut B, Basal FB, Budakoglu B, Sendur MAN, Goktas B, Ozdener F, Baygul A. A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study): A Turkish Oncology Group Study. Am J Clin Oncol. 2021 Jul 1;44(7):301-307. doi: 10.1097/COC.0000000000000825.
Results Reference
derived

Learn more about this trial

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

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