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Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01312350
First Posted: March 10, 2011
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
  Purpose
The investigators will examine whether 2-cycles of DFP chemotherapy before definitive concurrent chemoradiation therapy (CCRT) can improve progression-free survival in locally advanced (Stage III & IVM0) hypopharyngeal and base of tongue carcinoma compared to definitive CCRT alone.

Condition Intervention Phase
Hypopharyngeal Cancer Drug: neoadjuvant docetaxel/cisplatin/fluorouracil Drug: No treatment before definitive CCRT Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concurrent Chemoradiation Versus Induction Docetaxel, Cisplatin and 5-fluorouracil (TPF) Followed by Concomitant Chemoradiotherapy in Locally Advanced Hypopharyngeal and Base of Tongue Cancer: A Randomized Phase II Study

Resource links provided by NLM:


Further study details as provided by Keunchil Park, Samsung Medical Center:

Primary Outcome Measures:
  • To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patients ]

Secondary Outcome Measures:
  • To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only [ Time Frame: 18 months after enrollemnt of last patients ]
  • To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ]
  • To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only [ Time Frame: 18 months after the enrollment of the last patient ]

Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CCRT only arm
no neoadjuvant chemotherapy before definitive CCRT
Drug: No treatment before definitive CCRT
concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43
Experimental: neoadjuvant chemotherapy arm
2 cycles of TPF chemotherapy before definitive CCRT
Drug: neoadjuvant docetaxel/cisplatin/fluorouracil
2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.
Other Name: Docetaxel (taxotere)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically/cytologically proven stage III/IVM0 hypopharyngeal or base of tongue cancer
  • One or more evaluable or measurable lesion
  • No prior chemotherapy, radiation, or surgery
  • ECOG 0-2

Exclusion Criteria:

  • Distant metastasis
  • Other malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312350


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01312350     History of Changes
Other Study ID Numbers: 2010-10-028
First Submitted: February 21, 2011
First Posted: March 10, 2011
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Keunchil Park, Samsung Medical Center:
neoadjuvant chemotherapy
definitive chemoradiation therapy
head and neck cancer
base of tongue
Locally advanced

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs