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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01312350

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypopharyngeal Cancer	Drug: neoadjuvant docetaxel/cisplatin/fluorouracil Drug: No treatment before definitive CCRT	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Actual Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Docetaxel (taxotere)

Arm

Intervention/Treatment

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 Names:

Docetaxel (taxotere)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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