Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma (NPC-RCT-WCRT)

He Xia

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Nedaplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02301208

JiangsuCIH

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Low dose cisplatin arm

Active Comparator group

Description:

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

Treatment:

Drug: Cisplatin

High dose cisplatin arm

Active Comparator group

Description:

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

Treatment:

Drug: Cisplatin

Low dose nedaplatin arm

Experimental group

Description:

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

Treatment:

Drug: Nedaplatin

High dose nedaplatin arm

Experimental group

Description:

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

Treatment:

Drug: Nedaplatin