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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312350

Enrollment

Registered

2011-03-10

Start date

2010-11-30

Completion date

2018-12-31

Last updated

2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopharyngeal Cancer

Keywords

neoadjuvant chemotherapy, definitive chemoradiation therapy, head and neck cancer, base of tongue, Locally advanced

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.

Interventions

DRUGneoadjuvant 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.

DRUGNo treatment before definitive CCRT

concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To determine whether addition of neoadjuvant chemotherapy before definite CCRT increase progression-free survival(PFS) compared with CCRT only	18 months after the enrollment of the last patients

Secondary

Measure	Time frame
To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only	18 months after enrollemnt of last patients
To determine whether addtion of neoaduvant chemotherapy increase organ preservation rate compared with CCRT only	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	18 months after the enrollment of the last patient

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026