Study of Neoadjuvant Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy using gemcitabine and cisplatin in NPC patients.

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Detailed Description

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Patients presented with non-keratinizing NPC and stage Ⅲ-Ⅳb T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (gemcitabine+cisplatin) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical Intensity modulated radiation therapy (Trilogy, Varian), and cisplatin (40mg/m2) every weeks for six cycles during radiotherapy. Radiation is delivered to GTV at 70 Gy in 30 fractions, CTV1 at at 60 Gy in 30 fractions and CTV2 at 54 Gy in 30 fractions. Patients in the investigational arm receive gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy. The primary end point is response rates after radiotherapy, failure-free survival (FFS) and toxic effects and treatment compliance. Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS). All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Inductive and concurrent

Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.

Group Type EXPERIMENTAL

Drug: Gemcitabine and cisplatin

Intervention Type DRUG

Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.

Concurrent chemoradiotherapy

Patients receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy

Interventions

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Drug: Gemcitabine and cisplatin

Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.

Intervention Type DRUG

Cisplatin

Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy

Intervention Type DRUG

Other Intervention Names

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Gemcitabine and cisplatin

Eligibility Criteria

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Inclusion Criteria

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO 2005) histologically type).
* Karnofsky scale (KPS) \> 70.
* Tumor staged is according to the 7th American Joint Commission on Cancer edition as Stage III：T1-2N2M0, T3N0-2M0 Stage IVa：T4N0-2M0 Stage IVb：Any T、N3.
* Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
* Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
* Adequate renal function: creatinine clearance ≥60 ml/min.
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

* WHO Type keratinizing squamous cell carcinoma.
* Age \>60 years or \<18 years.
* Treatment with palliative intent.
* Pregnancy or lactation.
* Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* Any severe intercurrent disease including unstable cardiac disease, chronic hepatitis, renal disease, diabetes with poor control, and emotional disturbance.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No