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

This study is currently recruiting participants.
Verified March 2011 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01312350
First received: February 21, 2011
Last updated: March 8, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Primary Completion Date: August 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312350

Contacts
Contact: Keunchil Park, Pf 82-2-3410-3459 kpark@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: keunchil Park, Pf     822-3410-3459     kpark@skku.edu    
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Keunchil Park/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01312350     History of Changes
Other Study ID Numbers: 2010-10-028
Study First Received: February 21, 2011
Last Updated: March 8, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Hypopharyngeal Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
 Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013