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

Phase 2

Completed

• Conditions: Hypopharyngeal Cancer
• Interventions: Drug: No treatment before definitive CCRT; Drug: neoadjuvant docetaxel/cisplatin/fluorouracil

• Registration Number: NCT01312350
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Primary Completion: 2016-03
• Study Completion: 2018-12
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCRT only arm	No treatment before definitive CCRT	no neoadjuvant chemotherapy before definitive CCRT
neoadjuvant chemotherapy arm	neoadjuvant docetaxel/cisplatin/fluorouracil	2 cycles of TPF chemotherapy before definitive CCRT

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
To determine whether addtion of neoaduvant chemotherapy increase complete response rate compared with CCRT only	18 months after enrollemnt of last patients

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of