A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.
1 other identifier
interventional
53
1 country
2
Brief Summary
A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 15, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedJanuary 11, 2017
January 1, 2017
2.8 years
August 15, 2016
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
through study completion, an average of 1 year
Study Arms (1)
Arm 1
EXPERIMENTALS-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.
Interventions
Eligibility Criteria
You may qualify if:
- all proven to have locoregional recurrence after curative treatment and unsuitability for further local treatment, distant metastases at presentation or acquired metastases after curative treatment. the presence of at least one measurable disease, which was defined as lesion that could be measured at least 20 mm in one dimension by conventional computed tomography (CT) or at least 10 mm by spiral CT scan; KPS≥70, and a life expectancy of at least 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xiaozhong Chen
Hangzhou, Zhejiang, 310022, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2016
First Posted
August 25, 2016
Study Start
August 1, 2016
Primary Completion
June 1, 2019
Last Updated
January 11, 2017
Record last verified: 2017-01