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

NCT01748773 | Completed Phase 2 DMC

• 1 other identifier: ML25574
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 9

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to Month 13

• Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score

  From Baseline to Month 13

Secondary Outcomes (2)

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

  Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)

• Overall Survival

  Cycle 1 Day 1 up to death due to any reason (up to 24 months)

Study Arms (1)

Combination Therapy

EXPERIMENTAL

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

Drug: Oxaliplatin; Radiation: Radiation; Drug: Capecitabine; Drug: Trastuzumab

Interventions

Oxaliplatin DRUG

Participants will receive oxaliplatin 100 mg/m\^2 IV on Day 1 of Cycles 1-3.

Combination Therapy

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.

Combination Therapy

Capecitabine DRUG

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.

Combination Therapy

Trastuzumab DRUG

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).

Combination Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (9)

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, 01250, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Oncology Hospital; Oncology

Ankara, 06200, Turkey (Türkiye)

Location

Baskent University Medical Faculty; Internal Medicine

Ankara, 06490, Turkey (Türkiye)

Location

Bilkent Sehir Hospita; ONKOLOJI

Çankaya/Ankara, 06800, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty, Medical Oncology Department

Gaziantep, 27310, Turkey (Türkiye)

Location

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, 34890, Turkey (Türkiye)

Location

Ege Uni Medical Faculty; Oncology Dept

Izmir, 35100, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33979100 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Radiation; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 13, 2012
• Study Start: January 29, 2013
• Primary Completion: August 21, 2015
• Study Completion: June 15, 2017
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

TU (9)