NCT00778908

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

3 years

First QC Date

October 22, 2008

Last Update Submit

August 17, 2012

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinomaLocally advanced diseaseIntensity-modulated radiation therapyAccelerated hyperfractionationConcomitant boost radiation therapyConcurrent chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Local/regional control rate, Acute and late toxicities

    2-Yr

Secondary Outcomes (1)

  • Overall survival rate

    5-Yr

Study Arms (2)

A

EXPERIMENTAL

Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy

Radiation: Late-course accelerated hyperfractionated IMRTDrug: Concomitant cisplatin chemotherapy

B

OTHER

Conventionally fractionated IMRT with concomitant cisplatin chemotherapy

Drug: Concomitant cisplatin chemotherapyRadiation: Conventionally fractionated IMRT

Interventions

Late-course accelerated hyperfractionated IMRTRADIATION

1. IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease 2. 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.

A
Concomitant cisplatin chemotherapyDRUG

cisplatin:40mg/m2 weekly infusion for 6 weeks

AB
Conventionally fractionated IMRTRADIATION

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.

B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Heming Lu, MD

    Department of Radiation Oncology, People's Hospital of Guangxi Zhuang Autonomous Region

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

CN(1)