Clinical trial · Interventional
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT01689194CI-TRIAL-00048709completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| genexolPM + cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- genexolPM + cisplatin
- interventionNames
- Drug: genexolPM + cisplatin
Primary outcomes (1)
- measure
- response rate
- timeFrame
- every 2 cycles, 6wk later after chemotherapy
- description
- RECIST
Secondary outcomes (3)
- measure
- Locoregional control rate
- timeFrame
- every 3wk (every cycle)
- description
- NCI CTCAE
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * locally advanced head and neck squamous cell carcinoma * oral cavity, oropharynx, hypopharynx, larynx * measurable lesion * unresectable * age 18 or more * ECOG 0 or 1 Exclusion Criteria: * distant metastasis * pregnancy * prior chemotherapy or radiation therapy * 2ndary malignancy * other unfit medical condition
References
Publications (1)
- DERIVEDKeam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22. PMID 30796155