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

NCT ID: NCT01312350

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypopharyngeal Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCRT only arm

no neoadjuvant chemotherapy before definitive CCRT

Group Type ACTIVE_COMPARATOR

No treatment before definitive CCRT

Intervention Type DRUG

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

neoadjuvant chemotherapy arm

2 cycles of TPF chemotherapy before definitive CCRT

Group Type EXPERIMENTAL

neoadjuvant docetaxel/cisplatin/fluorouracil

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

No treatment before definitive CCRT

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

Intervention Type DRUG

Other Intervention Names

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Docetaxel (taxotere)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Keunchil Park

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2010-10-028

Identifier Type: -

Identifier Source: org_study_id