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Multicenter phase II trial of neoadjuvant chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

Multicenter phase II trial of neoadjuvant chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma - Phase II trial of neoadjuvant chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000023
Enrollment
30
Registered
2005-08-01
Start date
2004-06-01
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 (60 mg/m2) was administered intravenously for 1 h on day1. After completion of the docetaxel infusion, nedaplatin (100 mg/m2) was administered intravenously for another hour followed by 1,00

Sponsors

Chubu research group on oral cancer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) age between 20 and 75 years (patients aged >76 years were allowed if major organs functions was preserved), (2) Eastern Cooperative Oncology Group performance status (PS) score of 2 or less (3) adequate bone marrow function (4) adequate hepatic function (5) adequate renal function (6) 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
Clinical and histopathological effect of induction chemotherapy with docetaxel and nedaplatin for resectable oral squamous cell carcinoma

Secondary

MeasureTime frame
Safety of induction chemotherapy with docetaxel and nedaplatin for resectable oral squamous cell carcinoma

Countries

Japan

Outcome results

None listed

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