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Completed

NCT Number: NCT01689194

Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer

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.

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Key information

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genexolPM + cisplatin

Drug

Primary outcomes

  1. response rate

    Time frame: every 2 cycles, 6wk later after chemotherapy

    RECIST

Secondary outcomes

  1. Locoregional control rate

    Time frame: every 3wk (every cycle)

    NCI CTCAE

  2. Quality of life

    Time frame: every 3wk (every cycle)

    EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on)

  3. safety

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Clinical Research Center for Solid Tumor, Korea

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 21, 2012
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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