Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778908
• Other study ID #: GUIKEGONG-0816004-40
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 22, 2008
• Last updated: August 17, 2012
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Guangxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ?b-?b

• 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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Late-course accelerated hyperfractionated IMRT
IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.

Drug:
• Concomitant cisplatin chemotherapy
cisplatin:40mg/m2 weekly infusion for 6 weeks

Radiation:
• Conventionally fractionated IMRT
IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.

Locations

Country	Name	City	State
China	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi

Sponsors (3)

Lead Sponsor	Collaborator
Guangxi Medical University	Guangxi Sci-Tech Office, People's Hospital of Guangxi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local/regional control rate, Acute and late toxicities		2-Yr	Yes
Secondary	Overall survival rate		5-Yr	Yes

External Links

•   Guangxi Medical University
•   Guangxi Sci-Tech Office