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.

NCT ID: NCT02878889

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.

Group Type EXPERIMENTAL

S-1

Intervention Type DRUG

Interventions

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S-1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xiaozhong Chen, MD

Role: primary

+86-571-88122098

Xiaozhong Chen, MD

Role: primary

86-571-88122098

Other Identifiers

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NPC-16-01

Identifier Type: -

Identifier Source: org_study_id

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