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

Primary Purpose

Hypopharyngeal Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
neoadjuvant docetaxel/cisplatin/fluorouracil
No treatment before definitive CCRT
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypopharyngeal Cancer focused on measuring neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CCRT only arm

neoadjuvant chemotherapy arm

Arm Description

no neoadjuvant chemotherapy before definitive CCRT

2 cycles of TPF chemotherapy before definitive CCRT

Outcomes

Primary Outcome Measures

To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only

Secondary Outcome Measures

To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only
To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only
To determine whether addition of neoadjuvant chemotherapy to CCRT increase the number of patients with adverse events compared with CCRT only

Full Information

First Posted
February 21, 2011
Last Updated
December 5, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01312350
Brief Title
Neoadjuvant Chemotherapy for Locally Advanced Squamous Cell Cancer of the Head and Neck (SCCHN)
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypopharyngeal Cancer
Keywords
neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCRT only arm
Arm Type
Active Comparator
Arm Description
no neoadjuvant chemotherapy before definitive CCRT
Arm Title
neoadjuvant chemotherapy arm
Arm Type
Experimental
Arm Description
2 cycles of TPF chemotherapy before definitive CCRT
Intervention Type
Drug
Intervention Name(s)
neoadjuvant docetaxel/cisplatin/fluorouracil
Other Intervention Name(s)
Docetaxel (taxotere)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
No treatment before definitive CCRT
Intervention Description
concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only
Time Frame
18 months after enrollemnt of last patients
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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