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A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003) - A randomized phase ll study comparing neoadjuvant FAP and DCF for the resectable advanced esophageal cancer (OGSG 1003)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004616
Enrollment
160
Registered
2010-12-01
Start date
2010-11-29
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

Patients are stratified by the number of metastatic lymph node and the institute at the registration. Group A : FAP CDDP70mg/m2(day1) ADM35mg/m2(day1), and 5-FU700mg/m2(day1-7) following 3 week res

Sponsors

OGSG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Thoratic esophageal cancer proven squamous cell carcinoma histologically 2.cT1-4a without any distant metastasis (eligible if only with supraclavicular lymph node tumor) 3.patients older than 20 y.o. 4.PS(ECOG) : 0,1 or 2 5.without any prior chemotherapy for esophageal cancer 6.with good organ functions : WBC : 3,000/mm3 <= and >= 12,000/mm3 Neutrophile : 1,500/mm3 <= Hemoglobin : 9.0g/dl <= Platelet : 100,000/mm3 <= T.bil. : under one and a half time of normal limit AST,ALT : under two times of normal limit Creatinine clearance : >=60 (Eligeble in direct method or Cockcroft-Gault method) SpO2 >= 95% in room air 7.with written Informed Consent

Exclusion criteria

Exclusion criteria: 1.Unresectable due to severe organ dysfunction (brain, heart, lung, liver, and/or kidney) 2.With active double cancers 3.With the history of severe drug allergy 4.Pregnant and/or nursing women, or women who expect to be pregnant 5.Patients whom doctor in chief decides not to register to this study

Design outcomes

Primary

MeasureTime frame
Recurrence free survival

Secondary

MeasureTime frame
Rate of R0 resection Complications of surgery Overall survival Adverse events Response rates

Countries

Japan

Contacts

Public ContactHiroshi Furukawa

Kinki University School of Medicine Department of surgery

hiroshi.furukawa@tokushukai.jp072-366-0221

Outcome results

None listed

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