Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
Phase 2
Completed
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT01689194
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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
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Exclusion Criteria
- distant metastasis
- pregnancy
- prior chemotherapy or radiation therapy
- 2ndary malignancy
- other unfit medical condition
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description genexolPM + cisplatin genexolPM + cisplatin -
- Primary Outcome Measures
Name Time Method response rate every 2 cycles, 6wk later after chemotherapy RECIST
- Secondary Outcome Measures
Name Time Method Quality of life every 3wk (every cycle) EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)
Locoregional control rate every 3wk (every cycle) NCI CTCAE
safety every 3wk (every cycle) NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of