Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Guangxi Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Conventionally fractionated IMRT; Radiation: Late-course accelerated hyperfractionated IMRT; Drug: Concomitant cisplatin chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00778908

GUIKEGONG-0816004-40

Details and patient eligibility

About

Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent
• According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb
• Age between 18-70
• Karnofsky performance status ≥70
• WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl
• Without radiotherapy or chemotherapy
• Signed study-specific consent form prior to study entry

Exclusion criteria

• Patients with distant metastasis
• Pregnant or lactating women
• The presence of uncontrolled life-threatening illness
• Patients who received radiotherapy or chemotherapy previously

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

A

Experimental group

Description:

Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy

Treatment:

Radiation: Late-course accelerated hyperfractionated IMRT

Drug: Concomitant cisplatin chemotherapy

B

Other group

Description:

Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

Treatment:

Radiation: Conventionally fractionated IMRT

Drug: Concomitant cisplatin chemotherapy