Randomized Phase II trial of Docetaxel treatment vs Paclitaxel Treatment for advanced/metastatic esophageal cancer resistant to fluoropyrimidine and/or platinum compound (OGSG1201)

Phase 2

• Conditions: Advanced Esophageal Cancer

• Registration Number: JPRN-UMIN000007940
• Lead Sponsor: Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)

Brief Summary

OS was significantly longer in the PTX group than in the DTX group (median, 8.8 versus 7.3 months; hazard ratio [HR], 0.62; P = 0.047).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Study Completion: 2020-04-21
• Results First Posted: 2021-07-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1) With active double cancers (Simultaneous and/or prior cancer within 5 years) Except cancers resected completely by ER/ESD 2) With uncontrolled DM 3) With cardiac infarction within 6 months or unstable angina pectoris 4) Patients who are administered anti-arhythmia except Warfarin 5) Patients who are administered steroids continuously orally and/or intravenously 6) Patient with liver cirrhosis 7) Patient with active infection 8) Patients with peri-cardiac fluid, pleural fluid and/or ascites which needs drainage Except controlled pleural fluid or ascites 9) With a history of grade 2-4 allergic reaction By CTCAE version 4.0 10) with a history of grade 2-4 nerve disturbance by CTCAE version 4.0 11) with blood transfusion within 2 weeks and/or continuous bleeding 12) with a figure of interstitial pneumonitis except radiation pneumonitis 13) with a history of allergic reaction to polyoxyethylene-castor oil, castor oil or polysolbate 80 14) with metastatic lesion in the central nerve system 15) patient with psychological disorder who cannot participate in this regimen 16) women pregnant and/or nursing or men who like to have children in future 17) Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified