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Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma - Phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001860
Enrollment
18
Registered
2009-04-08
Start date
2008-04-01
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

Oral squamous cell carcinoma

Interventions

Docetaxel is administered intravenously for 1 h on day1. After completion of the docetaxel infusion, nedaplatin is administered intravenously for another hour followed by 1,000 ml or more hydration. T

Sponsors

Chubu research group on oral cancer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Case with oral squamous cell carcinoma histologically, (2) age between 20 and 80 years (patients aged >80 years were allowed if major organs functions was preserved), (3) Karnofsky Performance Status (PS) score of 2 or less (4) adequate bone marrow function (5) adequate hepatic function (6) adequate renal function (7) written informed consent.

Exclusion criteria

Exclusion criteria: Patients were excluded if they had active infections, active second malignancy, severe heart diseases, interstitial pneumonia or lung fibrosis, severe pleural effusion or pericardial effusion that required drainage, fever more than or equal to 38 C, symptomatic brain metastasis, severe psychological disease, and possible pregnancy.

Design outcomes

Primary

MeasureTime frame
Safety of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma

Secondary

MeasureTime frame
Clinical and histopathological effect of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma

Countries

Japan

Contacts

Public ContactHiroshi Kurita

Shinshu University School of Medicine Department of Dentistry and Oral surgery

hkurita@shinshu-u.ac.jp0263-37-2675

Outcome results

None listed

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