Clinical trial · Interventional
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
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
- interventionNames
- Drug: Oxaliplatin
- Radiation: Radiation
- Drug: Capecitabine
- Drug: Trastuzumab
Primary outcomes (2)
- measure
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to Month 13
- measure
- Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
- timeFrame
- From Baseline to Month 13
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAbali 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