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The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients

The phase II study of induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients - Induction chemotherapy with cetuximab/S-1/low dose cisplatin for oral squamous cell carcinoma patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014632
Enrollment
55
Registered
2014-07-25
Start date
2014-08-01
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

Induction chemotherapy Cetuximab day1(400mg/m2), day 8 (250mg/m2) S-1 day 1-14 (80mg/m2) CDDP day 1-5,8-12 (5mg/m2)

Sponsors

The workshop of chemotherapy for oral cancer
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically confirmed SCC 2) measurable and evaluable tumor 3) untreated case with more than large T2 (maximum size >3cm) tumor 4) Performance status 0-1 5) The functions of main organ (bone marrow, heart, lung, liver, kidney) are almost normal.

Exclusion criteria

Exclusion criteria: 1) double cancer case 2) severe systemic complications 3) metastasis to CNS 4) ischemic heart disease 5) active gastrointestinal ulcer 6) severe mental disorder 7) women who are fertile or during pregnancy 8) past illness of severe drug allergy 9) attending doctor's decision as unsuitable patient for this study

Design outcomes

Primary

MeasureTime frame
histological effect (histological response rate)

Secondary

MeasureTime frame
overall survival, disease-free survival, complication after surgery, the rate of avoidance of reconstructive surgery

Countries

Japan

Contacts

Public ContactMitsuhiro Nakazawa

Osaka university dental hospital 2nd dept. of oral & maxillofacial surgery

nakazawa@dent.osaka-u.ac.jp06-6879-2941

Outcome results

None listed

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