Clinical trial · Interventional
Chemotherapy for Patients With Cancer of the Stomach
Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric
NCT01928524CI-TRIAL-00050081DOScompletedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DOS2w Dose level 1A | Drug | — | UNRESOLVED |
| DOS2w Dose level 2A | Drug | — | UNRESOLVED |
| DOS2w Dose level 3A | Drug | — | UNRESOLVED |
| DOS2w Dose level 4A | Drug | — | UNRESOLVED |
| DOS3w Dose level 1B | Drug | — | UNRESOLVED |
| DOS3w Dose level 2B | Drug | — | UNRESOLVED |
| DOS3w Dose level 3B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- DOS2W Dose level 1A
- description
- Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
- interventionNames
- Drug: DOS2w Dose level 1A
- type
- EXPERIMENTAL
- label
- DOS2W Dose level 2A
- description
- Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
- interventionNames
- Drug: DOS2w Dose level 2A
- type
- EXPERIMENTAL
- label
- DOS2W Dose level 3A
- description
- Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological proven adenocarcinoma of the esophagus or the ventricle (ECV), and which cannot be treated curatively. 2. Age ≥ 18 years. 3. WHO performance status 0-1. 4. Neutrophils ≥ 1,5 x 109/L and platelets ≥ 100 x 109/L. 5. Bilirubin ≤ 1,5 x UNL (Upper Normal Limit) and ASAT and/or ALAT ≤ 3 x UNL. 6. Creatinine-clearance ≥ 60 ml/min. 7. Planned first day of treatment within 8 days after inclusion in the study. 8. Signed consent form. Exclusion Criteria: 1. 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. 2. No sensory neuropathy. 3. No previously treatment with docetaxel, oxaliplatin or S1. 4. No clinical suspicion of brain metastases. 5. No cytotoxic treatment or other experimental treatment within 2 weeks of inclusion in the study. 6. Other serious disease (i.e. heart disease, AMI within 1 year or ongoing infection). 7. No pregnant women or women who are lactating. Patients who are not using contraception. 8. No known DPD-deficiency or known allergy to taxanes or platinum. 9. No signs of physical or mental illness that would prevent absorption of oral treatment.
References
Publications (1)
- RESULTPfeiffer P, Qvortrup C, Krogh M, Schoennemann K, Vestermark LW, Jensen HA, Bjerregaard JK. S-1 in combination with docetaxel and oxaliplatin in patients with advanced gastro-esophageal adenocarcinoma: two parallel phase 1/2a studies. Acta Oncol. 2017 Jan;56(1):46-51. doi: 10.1080/0284186X.2016.1257865. Epub 2016 Dec 2. PMID 27911128