Nasopharyngeal CarcinomaPhase 3NCT00535795
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
A Phase 3 study testing Radiation Therapy in people with Nasopharyngeal Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2007to Sep 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with nasopharyngeal Carcinoma
Who cannot join
- Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA
Read the detailed description
It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Radiation Therapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week. Receives: Radiation: Radiation Therapy |
| 2 | Experimental | Conventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week. Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasser Al Rajhi, MD, Principal investigator, KFSH&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535795
- Sponsor's protocol ID
- RAC#0971-004
- Status last verified
- Dec 2011
- First submitted
- 24 Sep 2007
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
- ClinicalTrials.gov ID
- NCT00535795
- Acronym / sponsor ID
- RAC#0971-004
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III: Assess conventional RT w/ conventional Plus accelerated boost RT in the treatment of nasopharyngeal CA
Detailed description
It's a phase III study to assess conventional Rad Therapy with conventional Plus accelerated boost Rad Therapy in the treatment of nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: Radiation TherapyConventional Radiation Therapy (XRT), one fraction per day, from Sunday to Thursday every week. |
| 2 | Experimental | Radiation: Radiation TherapyConventional Plus accelerated boost Radiation Therapy (XRT), from Sunday to Thursday every week. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with nasopharyngeal Carcinoma
Key exclusion criteria (1 listed)
- Patients with carcinoma other than histo-pathologically confirmed nasopharyngeal CA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyRadiation Therapy | Radiation | 1, 2 |
Primary outcome
safety and efficacy
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingObservational study
The Clinical Application Value of CAIX-Targeted PET Hypoxia Imaging in Malignant Tumors
Nasopharyngeal Cancers, Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Pembrolizumab + MRGOO3 as Neoadjuvant in NPC
NPC, Locoregionally Advanced Nasopharyngeal Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Al Rajhi, MD principal investigator
KFSH&RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation Therapy in people with Nasopharyngeal Carcinoma, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and efficacy (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.