Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments oxaliplatin, radiation, capecitabine, trastuzumab [herceptin]
Phase phase 2
Sponsor Hoffmann-La Roche
Start date January 2013
End date December 2017
Trial size 35 participants
Trial identifier NCT01748773, ML25574

Summary

This single arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine and Herceptin (trastuzumab) and chemoradiotherapy in the adjuvant setting in patients with curatively resected HER2-positive gastric or gastro-esophageal junction cancer. Patients will receive Herceptin 8 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 mg/m2 iv on Day 1 of Cycles 1-3 and capecitabine 850 mg/m2 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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
oxaliplatin
100 mg/m2 iv on Day 1, 3 cycles
radiation
Total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 22 (+/- 3 days) of Cycle 3
capecitabine
850 mg/m2 orally bid, Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy
trastuzumab [herceptin]
8 mg/kg iv on Day 1 Cycle 1, 6 mg/kg iv on Day 1 of each following 3-week cycle, 12 months

Primary Outcomes

Measure
Safety: Incidence of adverse events
time frame: 4 years

Secondary Outcomes

Measure
Disease-free survival
time frame: 4 years
Overall survival
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Adult patients, 18 to 75 years of age - Curatively resected HER2-positive gastric or gastro-esophageal junction adenocarcinoma; HER2+ status as defined by IHC2+ or IHC3+ with corroborative FISH+ result - Patients with Stage IB (T1N1M0) disease or higher, except metastatic (Stage IV) disease - Eastern Cooperative Oncology Group (ECOG) performance status /= 50% - No known contraindication to capecitabine, oxaliplatin or trastuzumab - No contraindication for radiotherapy or has not received any previous radiotherapy for any reason Exclusion Criteria: - Previous neoadjuvant chemotherapy and/or radiotherapy - Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastro-esophageal junction carcinoma) - Known (previously diagnosed and on-going) malabsorption syndrome - Active gastrointestinal bleeding - Any other malignancies within the past 5 years, except for squamous cell carcinoma of the skin - Clinically significant cardiac or cardiovascular disease - Uncontrolled hypertension - Patients who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study

Additional Information

Official title Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Adjuvant Setting in Operated HER2+ Patients With Gastric or Gastroesophageal Junction Adenocarcinoma: A Phase II Study (TOXAG Study)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.