- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01403259
SOX as Salvage Treatment in Nasopharyngeal Carcinoma
August 19, 2014 updated by: Ye Guo, Fudan University
Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited.
Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer.
Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer.
Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.
Study Type
Interventional
Enrollment (Actual)
16
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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Shanghai, China
- Fudan University Shanghai Cancer Center
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range: 18-75 years old
- Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
- Prior exposure of at least one line of platinum-containing regimen
- ECOG performance status 0-1
- Life expectancy of more than 3 months
- Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
- Liver function: total bilirubin, ALT and AST <1.5×UNL
- Renal function: Cr<1.5×UNL, CCR≧50ml/min
- Without > 1 grade of neuropathy
Exclusion Criteria:
- With curable treatment option
- With CNS involvement
- Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
- Treated with > 2 lines of palliative chemotherapy
- With prior exposure of S-1 or oxaliplatin
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- Significant active infection
- Pregnant or lactating women
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 |
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Experimental: S-1 plus oxaliplatin
S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles
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S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Median progression-free survival
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response rate
Time Frame: 6 weeks
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6 weeks
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Median overall survival
Time Frame: 1.5 year
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1.5 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2011
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (Estimate)
July 27, 2011
Study Record Updates
Last Update Posted (Estimate)
August 20, 2014
Last Update Submitted That Met QC Criteria
August 19, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Oxaliplatin
Other Study ID Numbers
- HNTG 11-02
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 Nasopharyngeal Carcinoma
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National Cancer Institute (NCI)NRG OncologyTerminatedRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Metastatic Nasopharyngeal Nonkeratinizing Carcinoma | Metastatic Nasopharyngeal Undifferentiated Carcinoma | Nasopharyngeal... and other conditionsUnited States, Canada, China, Singapore
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National Cancer Institute (NCI)CompletedRecurrent Nasopharynx Carcinoma | Stage III Nasopharyngeal Carcinoma AJCC v7 | Stage IV Nasopharyngeal Carcinoma AJCC v7 | Stage IVA Nasopharyngeal Carcinoma AJCC v7 | Stage IVB Nasopharyngeal Carcinoma AJCC v7 | Stage IVC Nasopharyngeal Carcinoma AJCC v7 | Nasopharyngeal Nonkeratinizing CarcinomaUnited States, Singapore, China
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National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage III Nasopharyngeal...United States, Canada
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Children's Oncology GroupNational Cancer Institute (NCI)CompletedStage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Stage II Nasopharyngeal Keratinizing... and other conditionsUnited States, Canada, Australia
-
Alain AlgaziAstraZeneca; Incyte CorporationWithdrawnRecurrent Nasopharyngeal Carcinoma | Metastatic Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma | Epstein-Barr Virus Positive | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma
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Alliance for Clinical Trials in OncologyNot yet recruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal Carcinoma
-
Stanford UniversityTerminatedStage IV Nasopharyngeal Carcinoma | Stage III Nasopharyngeal Carcinoma | Stage IVA Nasopharyngeal Carcinoma | Stage IVB Nasopharyngeal Carcinoma | Stage II Nasopharyngeal Carcinoma | Stage 0 Nasopharyngeal Carcinoma | Stage 0 Paranasal Sinus Cancer | Stage I Nasopharyngeal Carcinoma | Stage I Paranasal... and other conditionsUnited States
-
Gustave Roussy, Cancer Campus, Grand ParisUnknownLOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE UCNTFrance
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National Cancer Institute (NCI)Not yet recruitingStage IV Nasopharyngeal Carcinoma AJCC v8 | Stage II Nasopharyngeal Carcinoma AJCC v8 | Stage III Nasopharyngeal Carcinoma AJCC v8
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National Cancer Institute (NCI)RecruitingRecurrent Nasopharyngeal Carcinoma | Stage IV Nasopharyngeal Carcinoma AJCC v8 | Metastatic Nasopharyngeal CarcinomaUnited States, China
Clinical Trials on S-1 plus oxaliplatin
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Xijing HospitalUnknownGastrointestinal CancerChina
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Sun Yat-sen UniversityUnknown
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Peking University Cancer Hospital & InstituteRecruiting
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Yonsei UniversityTerminatedAdvanced Gastric CancerKorea, Republic of
-
Taiho Pharmaceutical Co., Ltd.Yakult Honsha Co., LTDCompletedGastric CancerJapan, Korea, Republic of
-
Lin ChenUnknownGastric AdenocarcinomaChina
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Zhejiang UniversityRecruitingLocally Advanced Gastric CarcinomaChina
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AIPING ZHOUNot yet recruitingImmunotherapy | Sintilimab | Locally Advanced Solid Tumor | Oxaliplatin | HER2-positive | Gastric or Gastroesophageal Junction Adenocarcinoma | S-1China
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First Affiliated Hospital, Sun Yat-Sen UniversityCompletedGastric Cancer | Surgery | Complement Component DeficiencyChina
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Sixth Affiliated Hospital, Sun Yat-sen UniversitySun Yat-sen UniversityRecruitingChemotherapy Effect | Locally Advanced Gastroesophageal Junction AdenocarcinomaChina