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A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma


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

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Trial Information

A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma


Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several
prospective randomized trials have demonstrated that concurrent chemoradiotherapy was
superior to radiotherapy alone in the treatment of locoregionally advanced NPC.
Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than
noncisplatin regimens. However, the patients' compliance was unsatisfactory because the
obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation
platinum and it has slight gastrointestinal reaction. Our trial is in order to study the
effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT)
chemoradiotherapy in treating patients with locoregionally advanced NPC.


Inclusion Criteria:



- Patients with newly histologically confirmed non-keratinizing nasopharyngeal
carcinoma, including WHO II or III

- Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition）

- No evidence of distant metastasis (M0)

- Male and no pregnant female

- Age between 18-65

- WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3

- With normal liver function test (ALT、AST ≤ 2.5×ULN)

- With normal renal function test (Creatinine ≤ 1.5×ULN)

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

- Without radiotherapy or chemotherapy

- Patients must give signed informed consent

Exclusion Criteria:

- Patients have evidence of relapse or distant metastasis

- The presence of uncontrolled life-threatening illness

- Receiving other ways of anti-cancer therapy

- Receiving radiotherapy or chemotherapy

- Pregnancy or lactation

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progress-free survival

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

HaiQiang Mai, MD,Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer center

Authority:

China: Ministry of Health

Study ID:

Sun Yat-sen University

NCT ID:

NCT01540136

Start Date:

February 2012

Completion Date:

December 2016

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Carcinoma
  • Nasopharyngeal Neoplasms

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