Nasopharyngeal CarcinomaPhase 2NCT01694576
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
A Phase 2 study testing Adjuvant chemotherapy with paclitaxel and nedaplatin in people with Nasopharyngeal Carcinoma, run by Jiangsu Cancer Institute & Hospital at 1 site in China.
Trial summary
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation? 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?
- Adjuvant chemotherapy with paclitaxel and nedaplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Oct 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed untreated NPC patients staged N2-3M0
- age: 18y - 65y
- 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 staged properly
- without written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
Read the detailed description
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Adjuvant chemotherapy with paclitaxel and nedaplatin
- Keywords
- Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapy with paclitaxel and nedaplatinDrug
Also called Adjuvant chemotherapy
Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant chemotherapy with paclitaxel and nedaplatin | Experimental | Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation Receives: Drug: Adjuvant chemotherapy with paclitaxel and nedaplatin |
| Observation | No intervention | Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment toxicity based on a CTCAE3.0 grading system
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 posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Why it stopped: slow patient enrollment
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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. and PhD, Principal investigator, Department of Radiotherapy,Jiangsu Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694576
- Sponsor's protocol ID
- NPC-N23-RCT
- Other IDs
- JSCC-RCT01
- Status last verified
- Jun 2015
- First submitted
- 17 Sep 2012
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
- ClinicalTrials.gov ID
- NCT01694576
- Acronym / sponsor ID
- NPC-N23-RCT
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma staged N2-3M0, Adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow patient enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 27 Sep 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.
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
Detailed description
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant chemotherapy with paclitaxel and nedaplatin | Experimental | Drug: Adjuvant chemotherapy with paclitaxel and nedaplatinPatients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation |
| Observation | No intervention | –Patients will be followed up without adjuvant chemotherapy after concurrent chemoradiation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pathologically confirmed untreated NPC patients staged N2-3M0
- age: 18y - 65y
- with MRI examinations
- ECOG≤2
- with written consent
Key exclusion criteria (5 listed)
- without a second cancer
- pregnancy
- with other severe diseases(blood,liver ,kidney or heart diseases)
- could not 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 |
|---|---|---|
| Adjuvant chemotherapy with paclitaxel and nedaplatinAlso: Adjuvant chemotherapyPatients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation | Drug | Adjuvant chemotherapy with paclitaxel and nedaplatin |
Primary outcome
treatment toxicity based on a CTCAE3.0 grading system
Time frame: 6 months
1 secondary outcome
progress free survival
Time frame: 24 months
Results and safety
The study was stopped early (reason given: slow patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
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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. and PhD principal investigator
Department of Radiotherapy,Jiangsu Cancer Hospital
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 Adjuvant chemotherapy with paclitaxel and nedaplatin 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 5 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: stopped early, as of the sponsor's last update on 15 Jun 2015. 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?
The study was stopped early (reason given: slow patient enrollment). Results are not available in the source record.
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?
treatment toxicity based on a CTCAE3.0 grading system (time frame: 6 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 15 Jun 2015.