Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Jiangsu Cancer Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nasopharyngeal Carcinoma

Treatments: Biological: Cetuximab; Radiation: Intensity-modulated radiotherapy; Drug: Concurrent chemotherapy with paclitaxel and nedaplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01712919

JSCC-SACT-01 (Other Identifier)

LA-chemoR-c225

Details and patient eligibility

About

The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed untreated NPC patients
• locoregionally advanced (T3-4 or N2-3 M0)
• 18-65 years
• with MRI examinations
• ECOG ≤ 2
• With written consent

Exclusion criteria

• Without 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

61 participants in 1 patient group

cetuximab

Experimental group

Description:

Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy.

Treatment:

Drug: Concurrent chemotherapy with paclitaxel and nedaplatin

Biological: Cetuximab

Radiation: Intensity-modulated radiotherapy