NCT00535795

Brief Summary

Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_3

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

September 1, 2007

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 1, 2019

Status Verified

December 1, 2011

Enrollment Period

8 years

First QC Date

September 24, 2007

Last Update Submit

February 28, 2019

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • safety and efficacy

    5 years

Study Arms (2)

1

ACTIVE COMPARATOR

Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week.

Radiation: Radiation Therapy

2

EXPERIMENTAL

Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week.

Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

Radiation Therapy

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with nasopharyngeal Carcinoma

You may not qualify if:

  • Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KFSH&RC

Riyadh, 1211, Saudi Arabia

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Nasser Al Rajhi, MD

    KFSH&RC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 1, 2019

Record last verified: 2011-12

Locations

SA(1)