Nasopharyngeal CarcinomaPhase 3NPC-RCT-WCRTNCT02301208
Weekly Cisplatin or Nedaplatin Concurrent With Intensity-modulated Radiation Therapy in Nasopharyngeal Carcinoma
A Phase 3 study testing Nedaplatin and Cisplatin in people with Nasopharyngeal Carcinoma, run by He Xia.
Trial summary
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Nedaplatin and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed untreated NPC patients
- T1-2N1-3M0 or T3-4NxM0
- 18-70 years old
- with MRI examinations
- ECOG ≤ 2
- With written consent
Who cannot join
- With a second cancer
- Pregnancy
- With other severe diseases (blood,liver ,kidney or heart diseases)
- Could not be staged properly
- Without written consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
This is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Nedaplatin, Cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NedaplatinDrug
Also called NDP
Nedaplatin combine with IMRT
CisplatinDrug
Also called PDD, DDP, CDDP
Cisplatin combine with IMRT
| Study group | Role | What they receive |
|---|---|---|
| Low dose cisplatin arm | Active comparator | concurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy Receives: Drug: Cisplatin |
| High dose cisplatin arm | Active comparator | concurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy Receives: Drug: Cisplatin |
| Low dose nedaplatin arm | Experimental | concurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy Receives: Drug: Nedaplatin |
| High dose nedaplatin arm | Experimental | concurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy Receives: Drug: Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 2 years
Progress-free survival
Measured: 2 years
Secondary outcomes (2)
Tumor response
Measured: radiotherapy in 2 week、4 week、7 week
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Xia, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301208
- Sponsor's protocol ID
- JiangsuCIH
- Acronym
- NPC-RCT-WCRT
- Status last verified
- Dec 2014
- First submitted
- 19 Nov 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Concurrent Weekly Nedaplatin or Cisplatin With IMRT in NPC Patients
- ClinicalTrials.gov ID
- NCT02301208
- Acronym / sponsor ID
- NPC-RCT-WCRT / JiangsuCIH
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- He XiaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2014 (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 is a randomized Phase III study to evaluate efficancy of weekly cisplatin or nedaplatin concurrent with Intensity-modulated radiation therapy in Nasopharyngeal Carcinoma (NPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose cisplatin arm | Active comparator | Drug: Cisplatinconcurrent chemotherapy: cisplatin 20mg/m2,weekly,for 6 cycles during radiotherapy |
| High dose cisplatin arm | Active comparator | Drug: Cisplatinconcurrent chemotherapy: cisplatin 30mg/m2,weekly,for 6 cycles during radiotherapy |
| Low dose nedaplatin arm | Experimental | Drug: Nedaplatinconcurrent chemotherapy: nedaplatin 20mg/m2,weekly,for 6 cycles during radiotherapy |
| High dose nedaplatin arm | Experimental | Drug: Nedaplatinconcurrent chemotherapy: nedaplatin 30mg/m2,weekly,for 6 cycles during radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed untreated NPC patients
- T1-2N1-3M0 or T3-4NxM0
- 18-70 years old
- with MRI examinations
- ECOG ≤ 2
Key exclusion criteria (5 listed)
- With a second cancer
- Pregnancy
- With other severe diseases (blood,liver ,kidney or heart diseases)
- Could not be staged properly
- Without written consent
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 |
|---|---|---|
| NedaplatinAlso: NDPNedaplatin combine with IMRT | Drug | High dose nedaplatin arm, Low dose nedaplatin arm |
| CisplatinAlso: PDD, DDP, CDDPCisplatin combine with IMRT | Drug | High dose cisplatin arm, Low dose cisplatin arm |
Primary outcome
Response rate
Time frame: 2 years
Progress-free survival
Time frame: 2 years
2 secondary outcomes
Tumor response
Time frame: radiotherapy in 2 week、4 week、7 week
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nedaplatin and Cisplatin in people with Nasopharyngeal Carcinoma, run by He Xia.
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 6 inclusion and 5 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 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yin, M.D. Ph.D. (+8613913909043, yinli7878@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 2 years). The study lists 2 primary outcomes in all. 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 8 Dec 2014.