Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated radiotherapyIntensity-modulated Radiotherapy With or Without Concurrent Cisplatin for NPC

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/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-12-31

Brief Summary

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Concurrent cisplatin-based chemotherapy plus radiotherapy increased the risk of treatment-related death and severe acute toxicity. The survival benefit of adding concurrent chemotherapy to intensity modulated radiation in patients with locoregionally advanced nasopharyngeal carcinoma is unclear. Gemcitabine plus cisplatin chemotherapy combine with radiotherapy was effective and well tolerated by patients with locoregionally advanced NPC.

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Detailed Description

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The purpose of this study is to compare gemcitabine plus cisplatin induction chemotherapy combine intensity-modulated radiotherapy with or without concurrent cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to reevaluate the value of concurrent cisplatin when 4 cycles induction chemotherapy (gemcitabine+cisplatin) and IMRT is used.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IInductive chemotherapy + concurrent cisplatin and IMRT

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.

Group Type EXPERIMENTAL

Inductive chemotherapy + concurrent cisplatin and IMRT

Intervention Type DRUG

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.

Inductive chemotherapy + IMRT

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.

Group Type EXPERIMENTAL

Inductive chemotherapy + IMRT

Intervention Type DRUG

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.

Interventions

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Inductive chemotherapy + concurrent cisplatin and IMRT

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.

Intervention Type DRUG

Inductive chemotherapy + IMRT

Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.

Intervention Type DRUG

Other Intervention Names

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Gemcitabine and cisplatin 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).
* A Karnofsky performance status of at least 80;
* 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: a WBC ≥3.5×109 l-1; a platelet count ≥100×109 l-1; and hemoglobin levels ≥100 g/l.
* 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: a creatinine clearance rate of at least 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 \>65 years or \<18 years.
* Distant metastasis,
* Treatment with palliative intent.
* Pregnancy or lactation.
* a history of previous radiotherapy in the nasopharyngeal region or previous chemotherapy.
* history of renal disease, unstable cardiac disease requiring treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No