CompletedPhase 1

Chemotherapy for Patients With Cancer of the Stomach

Denmark34 participantsStarted 2013-09

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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.

What they're measuring

Median Overall Survival

Timeframe: Up to 2 years after first administration of DOS

Trial details

NCT IDNCT01928524

SponsorPer Pfeiffer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06-05

Results submitted2020-10-29

View on ClinicalTrials.gov More First-line Treatment for Patients With Non-resectable Gastric Cancer or Cancer of the Esophagus or trials