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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Inductive chemotherapy + concurrent cisplatin and IMRT; Drug: Inductive chemotherapy + IMRT

• Registration Number: NCT01854203
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-14
• Study First Posted: 2013-05-15
• Status Verified: 2013-07
• Study Start: 2013-07
• Last Update Submitted: 2013-07-28
• Last Update Posted: 2013-07-30
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IInductive chemotherapy + concurrent cisplatin and IMRT	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 (30 mg/m2，on day 1) repeated every weeks for 6 cycles during radiotherapy.
Inductive chemotherapy + IMRT	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	3-year	Overall survival is calculated from randomization to death from any cause.
Failure-free survival	3-year	Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
Locoregional failure-free survival	3-year	the latency to the first local failure
Distant failure-free survival	3-year	The latency to the first remote failure

Secondary Outcome Measures

Name	Time	Method
Difference in the complete response rates between the two treatment arms	12 weeks after the completion of therapy

Trial Locations

Locations (2)

State Key Laboratory of Oncology in South China, Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, China

Cancer Center,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China