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the phase I study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer

the phase I study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer - the phase I study of DNF therapy to esophageal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005083
Enrollment
18
Registered
2011-02-14
Start date
2008-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

StageII,III,IV non-resective esophageal cancer and recurrece ofesophageal cancer

Interventions

2008/8-2010/8 nedaplatin 60-80mg/m2 Doc 50-70mg/m2 5FU 600-800mg/m2/day

Sponsors

Gunma University Graduate School Department of General Surgical Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.It is diagnosed as an esophageal carcinoma for histopathology or cytology. 2.It is advanced unresectable esophageal cancer (StageII, III or IV) or esophageal carcinoma recurrent. 3.the interval between last treatment(radiation, chemotherapy) and this study is 4 weeks or more. 4.There is evaluable lesion for treatment. 5.ECOG Performance status is 0-2. 6.We satisfy all the following conditions. that examination of an equal day two weeks of registration day ago permits it (1)4,000 white blood corpuscle >= /mm3 and 12,000 <= /mm3 (2)2,000 mature granulocyte >= /mm3 (3)100,000 blood platelet >= /mm3 (4)Haemoglobin >= 9.5g/dL (5)1.5 fold upper limit in the hospital AST <= IU/L (6)1.5 fold upper limit in the hospital ALT <= IU/L (7)Bilirubin total <= 1.5mg/dL (8)2.5 fold upper limit in the hospital Al-P <= IU/L (9)Creatinine <= 1.2mg/dL (10)PaO2 >= 60 torr (room air) 7.expected prognosis is 3 months or more. 8.About final examination participation, an agreement by a document from the person himself is obtained.

Exclusion criteria

Exclusion criteria: 1.It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical. 2.Severe complicate disease (malignant hypertension, severe heart failure, liver failure, liver cirrhosis, diabetes mellitus under inadequate control, bleeding disorders) 3.Infectious disease with fever up 4.Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy, severe edema 5.pleural effusion or cardiac effusion need to treatment. 6.The patient having active multiple primary cancer. 7.During the pregnancy or a pregnant female patient we are possible or are nursing. 8.The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis 9.The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination. 10.the case that resarch contact doctor regards as inadequate.

Design outcomes

Primary

MeasureTime frame
Decision of a recommended dosage

Countries

Japan

Contacts

Public ContactTatsuya Miyazaki

Gunma University Graduate School Department of General Surgical Science

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026