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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01312350
First received: February 21, 2011
Last updated: May 29, 2013
Last verified: May 2013

February 21, 2011
May 29, 2013
November 2010
August 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01312350 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypopharyngeal Cancer
  • 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)
  • Drug: No treatment before definitive CCRT
    concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43
  • Active Comparator: CCRT only arm
    no neoadjuvant chemotherapy before definitive CCRT
    Intervention: Drug: No treatment before definitive CCRT
  • Experimental: neoadjuvant chemotherapy arm
    2 cycles of TPF chemotherapy before definitive CCRT
    Intervention: Drug: neoadjuvant docetaxel/cisplatin/fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
August 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Keunchil Park, Pf 82-2-3410-3459 kpark@skku.edu
Korea, Republic of
 
NCT01312350
2010-10-028
No
Keunchil Park, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP