Phase 1
Completed N=34
Chemotherapy for Patients With Cancer of the Stomach
Source: ClinicalTrials.gov NCT01928524 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
Feb 2021
Primary outcomePrimary: Median Overall Survival — 4.3; 13.8; 14.6; 15.2 Months
Summary
The purpose of this study is to determine maximal tolerable dose (MTD) of the combination of docetaxel, oxaliplatin and S1 (DOS) to patients with gastric cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival |
4.3; 13.8; 14.6; 15.2; 8.3; 16.4 | — |
Eligibility Criteria
Inclusion Criteria
- Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively.
- Age ≥ 18 years.
- WHO performance status 0-1.
- Neutrophils ≥ 1, 5 x 109/L and platelets ≥ 100 x 109/L.
- Bilirubin ≤ 1, 5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL.
- Creatinine-clearance ≥ 60 ml/min.
- Planned first day of treatment within 8 days after inclusion in the study.
- Signed consent form.
Exclusion Criteria
- No previous treatment with chemotherapy, except for (neo)-adjuvant chemotherapy for adenocarcinoma - treatment should have been completed at least 6 months before entrance in this study.
- No sensory neuropathy.
- No previously treatment with docetaxel, oxaliplatin or S1.
- No clinical suspicion of brain metastases.
- No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study.
- Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection).
- No pregnant women or women who are lactating. Patients who are not using contraception.
- No known DPD-deficiency or known allergy to taxanes or platinum.
- No signs of physical or mental illness that would prevent absorption of oral treatment.
Data sourced from ClinicalTrials.gov (NCT01928524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.