Nasopharyngeal CarcinomaPhase 1/2NCT01712919
Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)
A Phase 1/2 study testing Intensity-modulated radiotherapy, Concurrent chemotherapy with paclitaxel and nedaplatin and Cetuximab in people with Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Intensity-modulated radiotherapy, Concurrent chemotherapy with paclitaxel and nedaplatin and Cetuximab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Mar 2014
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed untreated NPC patients
- locoregionally advanced (T3-4 or N2-3 M0)
- 18-65 years
- with MRI examinations
- ECOG ≤ 2
- With written consent
Who cannot join
- Without 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
1 site in 1 country.
About this study
Official title: IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intensity-modulated radiotherapy, Concurrent chemotherapy with paclitaxel and nedaplatin, Cetuximab
- Keywords
- Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-modulated radiotherapyRadiation
Patients will be given intensity-modulated radiotherapy(IMRT)
Concurrent chemotherapy with paclitaxel and nedaplatinDrug
Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin
CetuximabBiological
Patients will be given cetuximab weekly during radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| cetuximab | Experimental | Patients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy. Receives: Radiation: Intensity-modulated radiotherapy; Drug: Concurrent chemotherapy with paclitaxel and nedaplatin; Biological: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety
Measured: 6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Measured: 6 months
Secondary outcomes (1)
Progress free survival
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startMay 2010
- Primary completionMar 2014
- Study completionMar 2014
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Xia He, Jiangsu Cancer Institute & Hospital
- Investigators
- Xia He, M.D. Ph.D., Principal investigator, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712919
- Sponsor's protocol ID
- LA-chemoR-c225
- Other IDs
- JSCC-SACT-01
- Status last verified
- Mar 2014
- First submitted
- 18 Oct 2012
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMRT With Concurrent Chemotherapy and Cetuximab Against Locoregionally Advanced NPC: a Phase 1 Study
- ClinicalTrials.gov ID
- NCT01712919
- Acronym / sponsor ID
- LA-chemoR-c225
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Locoregionally advanced nasopharyngeal carcinoma, cetuximab, chemoradiation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Oct 2012 (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.
The investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced Nasopharyngeal Carcinoma (NPC), and evaluate the toxicity and efficacy of this new regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cetuximab | Experimental | Radiation: Intensity-modulated radiotherapy, Drug: Concurrent chemotherapy with paclitaxel and nedaplatin, Biological: CetuximabPatients will be given intensity-modulated radiotherapy,2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin,and weekly cetuximab during radiation therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed untreated NPC patients
- locoregionally advanced (T3-4 or N2-3 M0)
- 18-65 years
- with MRI examinations
- ECOG ≤ 2
Key exclusion criteria (5 listed)
- Without 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 |
|---|---|---|
| Intensity-modulated radiotherapyPatients will be given intensity-modulated radiotherapy(IMRT) | Radiation | cetuximab |
| Concurrent chemotherapy with paclitaxel and nedaplatinPatients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin | Drug | cetuximab |
| CetuximabPatients will be given cetuximab weekly during radiation therapy | Biological | cetuximab |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and tolerability
Time frame: 6 months
1 secondary outcome
Progress free survival
Time frame: 24 months
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 24 Mar 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.
Xia He, M.D. Ph.D. principal investigator
Jiangsu Cancer Institute & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intensity-modulated radiotherapy, Concurrent chemotherapy with paclitaxel and nedaplatin and Cetuximab in people with Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital 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 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: finished, as of the sponsor's last update on 24 Mar 2014. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Number of Participants with Adverse Events as a Measure of Safety (time frame: 6 months). 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 24 Mar 2014.