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A study of the effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) for patients with esophageal cancer who receive DCF therapy.

A study of the effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) for patients with esophageal cancer who receive DCF therapy. - A study of the effectiveness of prophylactic G-CSF for patients with esophageal cancer who receive DCF therapy.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015561
Enrollment
23
Registered
2014-10-30
Start date
2014-10-30
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

esophageal cancer

Interventions

Subcutaneously injection of 50mcg/m&amp
sup2
Filgrastim as G-CSF by the following dose from day 7 to 13 of DCF 1 kur.

Sponsors

Osaka University School of Medicine Gastroenterological Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed esophageal cancer. 2.Patients who receive DCF therapy. 3.ECOG PS0-2. 4.Adequate organ function according to following laboratory values obtained within 14 days before enrolement. CCr>=60ml/min T-Bil<=1.5mg/dl AST&ALT<=100IU/l Hb>=8g/dl Plt>=10x10^4/mm3 5.Written informed concent.

Exclusion criteria

Exclusion criteria: 1.G-CSF hypersensitivity. 2.Administration of G-CSF within 6 weeks. 3.Infection within 2 weeks. 4.Past history of chemotherapy or radiation therapy. 5.Patients who are pregnant, lactating, with child-bearing potential. 6.Patients who is judged by the investigator to be inappropriate for study participation for any reason.

Design outcomes

Primary

MeasureTime frame
incidence of febrile neutropenia

Secondary

MeasureTime frame
incidence of myelosupression, duration of neutropenia, adverse event

Countries

Japan

Contacts

Public ContactMakoto Yamasaki

Osaka University School of Medicine Gastroenterological Surgery

myamasaki@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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