Nasopharyngeal CarcinomaPhase 2NCT01265147
Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma
A Phase 2 study testing Cisplatin and Nedaplatin in people with Nasopharyngeal Carcinoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which one is better efficacy and security in nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Cisplatin and Nedaplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2017
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18,T1-2aN1-3;T2-4NxNPC,VEGFR+,++,KPS>70,Life expectancy≥6 months, No uncontrolled hypertension,cardiac failure,diabetes,lunacy
Who cannot join
- Distant metastasis, recurrent disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study to Evaluate Efficacy and Safety of Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Patients With Nasopharyngeal Carcinoma
This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which one is better efficacy and security in nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Cisplatin, Nedaplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
40mg/m2/w
NedaplatinDrug
40mg/m2/w
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Active comparator | cisplatin combine with IMRT Receives: Drug: Cisplatin |
| Nedaplatin | Experimental | Nedaplatin combine with IMRT Receives: Drug: Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregionally control rate
3 months after treatment
Measured: 3 months
Secondary outcomes (1)
Survival
1 year Progress Free Survival,Disease Free Survival,3 years and 5 years Over All Survival,Safety
Measured: 1,3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2017 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265147
- Sponsor's protocol ID
- Daping H 001
- Status last verified
- Nov 2010
- First submitted
- 3 Dec 2010
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Efficacy and Safety of Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Patients With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01265147
- Acronym / sponsor ID
- Daping H 001
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 23 Dec 2010 (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.
This phase II trial is studying cisplatin or nedaplatin combine with IMRT to evaluate which one is better efficacy and security in nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Active comparator | Drug: Cisplatincisplatin combine with IMRT |
| Nedaplatin | Experimental | Drug: NedaplatinNedaplatin combine with IMRT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age≥18,T1-2aN1-3;T2-4NxNPC,VEGFR+,++,KPS>70,Life expectancy≥6 months, No uncontrolled hypertension,cardiac failure,diabetes,lunacy
Key exclusion criteria (1 listed)
- Distant metastasis, recurrent disease
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 |
|---|---|---|
| Cisplatin40mg/m2/w | Drug | Cisplatin |
| Nedaplatin40mg/m2/w | Drug | Nedaplatin |
Primary outcome
locoregionally control rate
Time frame: 3 months
3 months after treatment
1 secondary outcome
Survival
Time frame: 1,3,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Nedaplatin in people with Nasopharyngeal Carcinoma, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 20 Jan 2011. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhou Yang, Dr. (86(23)68757182, yangzhenzhou@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
locoregionally control rate (time frame: 3 months). 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 20 Jan 2011.