Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer

NCT01645748 | Completed Phase 2 DMC

• 2 other identifiers: CNUHH-MO-02CNUHH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the tolerability and efficacy of a combination of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; docetaxel; cisplatin; S-1

Outcome Measures

Primary Outcomes (1)

• Response rate

  After completion of CCRT, response rate was assessed. Patients underwent examination by an otolaryngologist, CT or MRI imaging of the primary tumor and neck. A biopsy of the primary site was recommended if possible. Tumor response was assessed according to the RECIST. For all patients with complete response (CR) on physical examination and CT or MRI scan, PET scan was performed for confirmation at 1 month after CT or MRI confirmation.

  Response rate was evaluated 1 months after completion of CCRT

Secondary Outcomes (3)

• Safety

  From initiation of induction chemotherapy up to 18 weeks

• Progression free survival

  From initiation of treatment up to 2 years

• Overall survival

  From initiatin of treatment up to 2 years

Study Arms (1)

S-1, induction chemotherapy

EXPERIMENTAL

Cisplatin and 5-FU is the standard treatment for patients with head and neck cancer. Recently,docetaxel was used into CF, and it showed the prolongation of survival. Oral 5-FU showed similar or enhanced response rate, safety than intravenous 5-FU. S-1 showed promising preliminary result in combination with cisplatin in head and neck cancer. In patients with gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid, 60mg/m2 (D1) and 60mg/m2 (D1), respectively. And weekly docetaxel can reduce adverse events compared to 3 week regimen. The aim of this study was to evaluate the efficacy and safety of weekly docetaxel, cisplatin and S-1 combination chemotherapy

Drug: S-1

Interventions

S-1 DRUG

S-1 is an oral fluoropyrimidine derivative, based on the concept of biochemical modulation. It consists in a molar ratio of 1:0.4:1: tegafur, a prodrug that is slowly metabolized to 5-fluorouracil; gimeracil, which reversibly inhibits dihydropyrimidine dehydrogenase. In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively.

Also known as: TS-1

S-1, induction chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx
• ≥18 years old
• absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL
• serum bilirubin \<2.0 mg/dL
• creatinine \<1.5 mg/dL
• serum transaminase levels less than twice the upper limit of normal

You may not qualify if:

• received previous chemotherapy
• another malignancy
• current or history of distant metastasis
• history of clinically significant cardiac disease within 6 months
• active serious infection
• nasopharyngeal carcinoma
• psychiatric illness that would preclude obtaining informed consent

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Chungbuk National University: collaborator
• Chonbuk National University: collaborator
• Chungnam National University: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Gwangju, Jeollanamdo, 519-809, South Korea

Location

Related Publications (1)

• Bae WK, Hwang JE, Shim HJ, Cho SH, Lee KH, Han HS, Song EK, Yun HJ, Cho IS, Lee JK, Lim SC, Chung WK, Chung IJ. Multicenter phase II study of weekly docetaxel, cisplatin, and S-1 (TPS) induction chemotherapy for locally advanced squamous cell cancer of the head and neck. BMC Cancer. 2013 Mar 6;13:102. doi: 10.1186/1471-2407-13-102.

  PMID: 23497365 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

S 1 (combination); titanium silicide; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sang-Hee Cho, M.D.Ph.D.

  CNUHH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 20, 2012
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

KR (1)