Trial | NCT02301208  Report issue

Title

Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma
A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).
Study Started
Dec 31
2014
Primary Completion
Dec 31
2016
Anticipated
Last Update
Dec 08
2014
Estimate

Drug Nedaplatin

Nedaplatin combine with IMRT

  • Other names: NDP

Drug Cisplatin

Cisplatin combine with IMRT

  • Other names: PDD, DDP, CDDP

Low dose cisplatin arm Active Comparator

concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

High dose cisplatin arm Active Comparator

concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

Low dose nedaplatin arm Experimental

concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy

High dose nedaplatin arm Experimental

concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy

Criteria 

Inclusion Criteria:

Pathologically confirmed untreated NPC patients
T1-2N1-3M0 or T3-4NxM0
18-70 years old
with MRI examinations
ECOG ≤ 2
With written consent

Exclusion Criteria:

With a second cancer
Pregnancy
With other severe diseases (blood,liver ,kidney or heart diseases)
Could not be staged properly
Without written consent
No Results Posted