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Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

Randomized Phase Ⅱ Trial of Induction Chemotherapy Using Gemcitabine and Cisplatin in Concurrence With Intensity-modulated Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Failure-free survival

Outcome Description:

Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Outcome Time Frame:

3-year

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

FSHNG-1108

NCT ID:

NCT01417390

Start Date:

November 2011

Completion Date:

December 2015

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms

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