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

Hypopharyngeal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312350
• Other study ID #: 2010-10-028
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: December 2018

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms

Intervention

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.
• No treatment before definitive CCRT
concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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