Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer

Randomised Phase II study of combined Docetaxel and Nedaplatin versus Docetaxel alone chemotherapy in advanced or recurrent esophageal cancer - ECDN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005877

Enrollment

Registered

2011-07-01

Start date

2011-07-01

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

Advanced or recurrent esophageal cancer

Interventions

NDP(80mg/m2) and DOC(60mg/m2) combination chemotherapy DOC (70mg/m2) chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.recurreent esophageal cancer 2.the tumor has a measurable lesion for evaluation. 3.5FU/CDDP resistance 4.ECOG PS:0 to 2 5.Age from 20 to 80 years 6.Adequate organ function WBC:>3,000/ mm3 <12,000/mm3 Neutro:>1,500/mm3 Hb:>9.0 g/dl Plt:>100,000/mm3 T-Bil:<1.5mg / dl AST(GOT),ALT(GPT):within 2.5 times the normal upper limits Ccr: 1.5mg/dl C.Cr:>50ml / min (Cockcroft- Gault) 7. Written informed consent

Exclusion criteria

Exclusion criteria: (1) patient who has drug allergy as past history 1. Known hypersensitivity to DOC, NDP and Polysorbate-80 2. patient who has active infectious disease 3. patient who has active double cancer 4. patient who has severe complication (interstitial pneumonitis, DM etc.) 5.concomitant treatment with steroids 6.EDEMA 7. patient who want to be pregnant and /or pregnant woman 8. patient who was judged to be unsuitable for this clinical trial

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
overall survival, one year survival rate, progression free survival, objective response rate, adverse events	—

Countries

Japan

Contacts

Public ContactSatoshi Yajima

Division of General and Gastroenterological Surgery, Department of Surgery (Omori), Toho University Department of Surgery

yajiman68@yahoo.co.jp0422577669

Outcome results

None listed

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