Know Cancer

or
forgot password

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma


Phase 2/Phase 3
18 Years
65 Years
Not Enrolling
Both
Nasopharyngeal Carcinoma

Thank you

Trial Information

Combination of Cisplatin Plus Gemcitabine Induction Chemotherapy and Intensity-modulated Radiotherapy With or Without Concurrent Cisplatin for Locoregionally Advanced Nasopharyngeal Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

Overall survival is calculated from randomization to death from any cause.

Outcome Time Frame:

3-year

Safety Issue:

No

Principal Investigator

yong Su, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

ChiECRCT-2013003

NCT ID:

NCT01854203

Start Date:

September 2013

Completion Date:

December 2016

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Cisplatin
  • neoadjuvant chemotherapy
  • intensity-modulated radiation therapy
  • concurrent chemoradiotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

Name

Location