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

NCT ID: NCT01748773

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-29
• Study Completion Date: 2017-06-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy

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

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

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

Radiation

Intervention Type: 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.

Capecitabine

Intervention Type: 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.

Trastuzumab

Intervention Type: 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).

Interventions

Oxaliplatin

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

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.

Intervention Type: 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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Adana, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Ankara, , Turkey (Türkiye)

Ankara Oncology Hospital; Oncology

Ankara, , Turkey (Türkiye)

Baskent University Medical Faculty; Internal Medicine

Ankara, , Turkey (Türkiye)

Bilkent Sehir Hospita; ONKOLOJI

Çankaya/Ankara, , Turkey (Türkiye)

Gaziantep University Medical Faculty, Medical Oncology Department

Gaziantep, , Turkey (Türkiye)

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, , Turkey (Türkiye)

Ege Uni Medical Faculty; Oncology Dept

Izmir, , Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 33979100 (View on PubMed)

Other Identifiers

ML25574

Identifier Type: -

Identifier Source: org_study_id