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Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 3
18 Years
59 Years
Not Enrolling
Nasopharyngeal Carcinoma

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Trial Information

Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy With or Without Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Patients Patients with non-keratinizing NPC T3-4N1M0/TxN2-3M0 (UICC/AJCC 7th edition) are
randomly assigned to receive induction chemotherapy plus CCRT or CCRT alone. Patients in
both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles, concurrently with
intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.27 Gy per fraction with five
daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary
tumor. The induction chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and
cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is
failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional
failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic
effects. All efficacy analyses are conducted in the intention-to-treat population, and the
safety population include only patients who receive their randomly assigned treatment.

Inclusion Criteria:

- Patients with newly histologically confirmed non-keratinizing (according to WHO
histologically type).

- Tumor staged as T3-4N1/N2-3 (according to the 7th AJCC edition).

- No evidence of distant metastasis (M0).

- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.

- Adequate marrow: leucocyte count ≥ 4000/μL, neutrophil count ≥ 2000/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 or basaloid squamous cell carcinoma.

- Age ≥ 60 or < 18.

- Treatment with palliative intent.

- Prior malignancy except adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer.

- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).

- History of previous RT (except for non-melanomatous skin cancers outside intended RT
treatment volume).

- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

- Any severe intercurrent disease, which may bring unacceptable risk or affect the
compliance of the trial, for example, unstable cardiac disease requiring treatment,
renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose
> 1.5×ULN), and emotional disturbance.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival

Outcome Description:

Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Jun Ma, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sun Yat-sen University


China: Ethics Committee

Study ID:




Start Date:

July 2013

Completion Date:

July 2020

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal carcinoma
  • Induction chemotherapy
  • Concurrent chemoradiotherapy
  • Clinical trial
  • Carcinoma
  • Nasopharyngeal Neoplasms