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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Hypopharyngeal Cancer

Treatments: Drug: neoadjuvant docetaxel/cisplatin/fluorouracil; Drug: No treatment before definitive CCRT

Study type: Interventional

Funder types: Other

Identifiers

NCT01312350

2010-10-028

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CCRT only arm

Active Comparator group

Description:

no neoadjuvant chemotherapy before definitive CCRT

Treatment:

Drug: No treatment before definitive CCRT

neoadjuvant chemotherapy arm

Experimental group

Description:

2 cycles of TPF chemotherapy before definitive CCRT

Treatment:

Drug: neoadjuvant docetaxel/cisplatin/fluorouracil