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Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma


Phase 3
18 Years
59 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma


Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly
assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus
concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control
arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every
three weeks for three cycles during radiotherapy. Patients in the investigational arm
receive docetaxel(60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2
on Days 1 to 5) every three weeks for three cycles before the radiotherapy. Patients are
stratified according to the treatment centers and stage. The primary end point is
failure-free survival (FFS). Secondary end points include overall survival (OS), distant
failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response
rates after treatments and toxic effects. 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) histologically type).

- Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer
edition).

- No evidence of distant metastasis (M0).

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

- 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 or basaloid squamous cell carcinoma.

- Age ≥60 years or <18 years.

- Treatment with palliative intent.

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

- Pregnancy or lactation.

- History of previous radiotherapy (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:

Interventional

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 is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Outcome Time Frame:

3-year

Safety Issue:

No

Principal Investigator

Jun Ma, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ethics Committee

Study ID:

YP2010171

NCT ID:

NCT01245959

Start Date:

January 2011

Completion Date:

April 2018

Related Keywords:

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

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