Phase II trial of 5FU/Docetaxel /Nedaplatin combination therapy for Recurrence or Metastatic Esophageal cancer

Phase 2

• Conditions: Esophageal cancer

• Registration Number: JPRN-UMIN000017685
• Lead Sponsor: Kinki university Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-27
• Study Completion: 2017-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1)Poorly controlled diabetes mellitus or routine administration of insulin. 2)Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 3)History of hypersensitivity to 5FU, DOC, CDGP, or polysorbate 80. 4)Active infection requiring systemic therapy. 5)Patients requiring systemic steroid medication. 6)Motor paralysis or peripheral neuropathy by any reason. 7)Edema by any reason. 8)Severe pulmonary fibrosis or emphysema. 9)A case with the past of radiotherapy or the chemotherapy within two weeks before registration. 10)With moderate or more ascites/pleural effusion or pericardial fluid. 11) Severe cardiac disease , or with a history of myocardial infarction within 6 months , or poorly controlled hypertension. 12)A case to have the past of the cerebrovascular disorder that developed within six months. 13)A case to have diarrhea continuously. 14)Case having the intestinal tract paralysis, ileus 15)Positive HBs antigen , or positive HIV antibody. 16)The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 17) During the pregnancy or a pregnant female patient we are possible or are nursing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified