Nasopharyngeal CancerPhase 2NCT01312311
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer
A Phase 2 study testing Docetaxel, Cisplatin in people with Nasopharyngeal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Docetaxel, Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2006to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed nasopharyngeal cancer
- chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
- ECOG 0-1
- at least one measurable lesion
Who cannot join
- other cancer
- pregnat
- docetaxel hypersentitivity history
- severe heart or pulmonary disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Myung-Ju Ahn, Pf, 822-3410-3459, silkahn@skku.edu
About this study
Official title: Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Docetaxel, Cisplatin
- Keywords
- nasopharyngeal cancer, weekly docetaxel, cisplatin
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, CisplatinDrug
Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1
| Study group | Role | What they receive |
|---|---|---|
| weekly docetaxel and cisplatin | Experimental | Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles Receives: Drug: Docetaxel, Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Measured: 6 months after the enrollment of the last patients
Secondary outcomes (1)
number of patients with adverse events
Measured: simultaneously when the analysis of primary endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJul 2006
- Primary completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312311
- Sponsor's protocol ID
- 2006-07-005
- Status last verified
- Mar 2011
- First submitted
- 21 Feb 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT01312311
- Acronym / sponsor ID
- 2006-07-005
- Conditions
- Nasopharyngeal Cancer
- Keywords
- nasopharyngeal cancer, weekly docetaxel, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2011 (estimated)
- First posted
- 10 Mar 2011 (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 evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weekly docetaxel and cisplatin | Experimental | Drug: Docetaxel, CisplatinDocetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically confirmed nasopharyngeal cancer
- chemotherapy or radiotherapy naive (but, including patients completed 6 months before the enrollment)
- ECOG 0-1
- at least one measurable lesion
Key exclusion criteria (4 listed)
- other cancer
- pregnat
- docetaxel hypersentitivity history
- severe heart or pulmonary 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 |
|---|---|---|
| Docetaxel, CisplatinDocetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 | Drug | weekly docetaxel and cisplatin |
Primary outcome
objective response rate
Time frame: 6 months after the enrollment of the last patients
1 secondary outcome
number of patients with adverse events
Time frame: simultaneously when the analysis of primary endpoint
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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 Docetaxel, Cisplatin in people with Nasopharyngeal Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 4 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 10 Mar 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 South Korea. 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 Myung-Ju Ahn, Pf (82-2-3410-3459, silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 6 months after the enrollment of the last patients). 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 10 Mar 2011; AzTrials last refreshed its copy on 4 Nov 2026.