- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645748
Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer (TPSHNSCC)
July 18, 2012 updated by: Sang-Hee Cho, Chonnam National University Hospital
Multicenter Phase II Study of Weekly Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Squamous Cell Cancer of the Head and Neck
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).
Study Overview
Status
Completed
Conditions
Detailed Description
Combination chemotherapy with cisplatin and fluorouracil (CF) is the standard treatment for patients with locally advanced squamous cancer of the head and neck.
CF chemotherapy has been reported to increase survival and disease free survival in patients with unresectable disease when given before definitive radiotherapy, showing overall response rate as 75-85% including of CR rate of 25-35%.
To improvement of treatment, docetaxel was incorporated into CF as induction treatment and it showed the prolongation of progression free survival and overall survival in large scale of randomized phase III trials, therefore triple combination induction regimen would be standard treatment in advanced head and neck cancer.
Recently, the introduction of oral fluoropyrimidine showed similar or enhanced response rate, also favorable safety and convenience than intravenous fluoropyrimidine in advanced gastric cancer.
Of the oral fluoropyrimidines, S-1 showed promising preliminary result in combination chemotherapy with cisplatin in head and neck cancer.
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, 60mg/m2 (D1) and 60mg/m2 (D1), respectively.
Therefore, the aim of this study was to evaluate the efficacy and safety of docetaxel, cisplatin and S-1 combination chemotherapy according to above dosage.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jeollanamdo
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Gwangju, Jeollanamdo, Korea, Republic of, 519-809
- Chonnam National University Hwasun Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: S-1, induction chemotherapy
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
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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.
Other Names:
Chemotherapy was comprised of docetaxel 30 mg/m2 on days 1 and 8, cisplatin 60 mg/m2 on day 1, and S-1 70 mg/m2 on days 1 to 14, with the regimen repeated every 21 days
Other Names:
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.
Another phase II study of TPS as induction chemotherapy for locally advanced HNSCC was determined to be 70/70/60 mg∙m2/d every 3 weeks.
However, the rate of grade 3-4 neutropenia was 75% at this recommended dose.
To reduce the hematologic toxicities, we used the docetaxel weekly.
Therefore following regimen was evaluated in this study; docetaxel 30 mg/m2 (D1, D8), cisplatin 60mg/m2 (D1), S-1 70mg/m2 (D1-D14) every 3 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: Response rate was evaluated 1 months after completion of CCRT
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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.
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Response rate was evaluated 1 months after completion of CCRT
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: From initiation of induction chemotherapy up to 18 weeks
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Number of participants with adverse events as a measure of safety according to NCI-CTC version 3.0 was checked every 3 weeks up to 18 weeks.
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From initiation of induction chemotherapy up to 18 weeks
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Progression free survival
Time Frame: From initiation of treatment up to 2 years
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Progression free survival means that the time from date of initiation of treatment until the date of first documented progression.
Patients who completed treatment were followed by physician examination and CT or MRI scanning every 3 months for 1 year and then these checkup was done every 6 months for another one year.
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From initiation of treatment up to 2 years
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Overall survival
Time Frame: From initiatin of treatment up to 2 years
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Overall survival means that the time from initiation of treatment until the date of death from any cause up to 2 years
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From initiatin of treatment up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
July 20, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNUHH-MO-02
- CNUHH (Other Grant/Funding Number: Jeil Pham)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
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Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
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Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
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Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
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IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
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University of California, San FranciscoCompleted
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Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
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Radboud University Medical CenterUnknown
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Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
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Zhejiang Cancer HospitalCompleted
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Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLCCompletedAdvanced Non-Small Cell Lung Cancer
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Hamamatsu UniversityUnknownGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Colon CancerJapan
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Taiho Oncology, Inc.Quintiles, Inc.; United BioSource, LLCCompletedLocally Advanced or Metastatic Pancreatic Cancer
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TTY BiopharmNational Taiwan University Hospital; Chang Gung Memorial Hospital; Taipei Veterans... and other collaboratorsTerminatedPancreatic Cancer | Adjuvant Chemotherapy | Resected Pancreatic CancerTaiwan
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Fudan UniversityCompletedNasopharyngeal CarcinomaChina