Chemotherapy for Patients With Cancer of the Stomach
DOS
Phase I Trial With Docetaxel, Oxaliplatin and S1 as First-line Treatment for Patients With Non-resectable Adenocarcinoma of the Esophagus or Gastric
Sponsor study identifier
interventional
34
1 country
1
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 5, 2015
Actual (reported)Study Completion
December 17, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 17, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2013
Actual (reported)August 26, 2013
Actual (reported)September 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 5, 2015
Actual (reported)December 17, 2015
Actual (reported)February 16, 2021
Actual (reported)Median Overall Survival
Up to 2 years after first administration of DOS
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Odense University Hospital
Odense, 5000, Denmark
Pfeiffer 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.
Per Pfeiffer, Professor
Odense University Hospital
34 participants (actual enrollment reported by the registry).
First Submitted
August 21, 2013
First Posted
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 2 weeks.
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Treatment with Docetaxel, Oxaliplatin and S1. Treatment is given every 3 weeks.
Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
August 26, 2013
Study Start
September 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 5, 2015
Actual (reported)Study Completion
December 17, 2015
Actual (reported)Last Updated
February 16, 2021
Results First Posted
February 16, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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