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A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Locally Advanced Head and Neck Squamous Cell Carcinoma

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Trial Information

A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Description:

RECIST

Outcome Time Frame:

every 2 cycles, 6wk later after chemotherapy

Safety Issue:

No

Principal Investigator

Se-Hoon Lee, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

CRCST-L-0007

NCT ID:

NCT01689194

Start Date:

February 2013

Completion Date:

February 2016

Related Keywords:

  • Locally Advanced Head and Neck Squamous Cell Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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