Nasopharyngeal NeoplasmsPhase 2NCT02360501
Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
A Phase 2 study testing Docetaxel, Cisplatin and Capecitabine in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- Docetaxel, Cisplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Apr 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage IVA and IVB nasopharyngeal carcinoma
- at lease one measurable lesion
- receive no chemotherapy or radiotherapy before
- Eastern CooperativeOncology Group performance status of 0 to 2.
- Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
Who cannot join
- mismatch the inclusion criteria
- previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
- allergy to any of these three drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
Read the detailed description
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- Docetaxel, Cisplatin, Capecitabine
- Keywords
- nasopharyngeal carcinoma, induction chemotherapy, docetaxel, xeloda
- Medical subject headings
- Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75mg/㎡,d1
CisplatinDrug
25mg/㎡,d1-3
CapecitabineDrug
Also called xeloda
2000mg/㎡,d1-14
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | docetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
overall response rate is the sum of complete response rate and partial response rate.
Measured: every 4 weeks,up to completion of treatment(approximately 6 months)
Secondary outcomes (4)
complete response rate
Measured: every 4 weeks,up to completion of treatment(approximately 6 months)
1 year progression free survival rate
Measured: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.
1 year overall survival rate
Measured: date from diagnosis of NPC to death of any cause (up to 12 months)
safety profiles (including hematologic toxicities and non-hematologic toxicities.)
including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).
Measured: date from diagnosis of NPC to completion of study (about 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2008
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Wang, Sun Yat-sen University
- Investigators
- Liang Wang, DOCTOR, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360501
- Sponsor's protocol ID
- DCX in NPC
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study
- ClinicalTrials.gov ID
- NCT02360501
- Acronym / sponsor ID
- DCX in NPC
- Conditions
- Nasopharyngeal Neoplasms
- Keywords
- nasopharyngeal carcinoma, induction chemotherapy, docetaxel, xeloda
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Feb 2015 (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 standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
Detailed description
The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: Capecitabinedocetaxel 75mg/㎡,d1; cisplatin 25mg/㎡,d1-3; capecitabine 2g/㎡, d1-14. repeated every three weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stage IVA and IVB nasopharyngeal carcinoma
- at lease one measurable lesion
- receive no chemotherapy or radiotherapy before
- Eastern CooperativeOncology Group performance status of 0 to 2.
- Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)
Key exclusion criteria (3 listed)
- mismatch the inclusion criteria
- previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
- allergy to any of these three drugs
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 |
|---|---|---|
| DocetaxelAlso: Taxotere75mg/㎡,d1 | Drug | treatment arm |
| Cisplatin25mg/㎡,d1-3 | Drug | treatment arm |
| CapecitabineAlso: xeloda2000mg/㎡,d1-14 | Drug | treatment arm |
Primary outcome
overall response rate
Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)
overall response rate is the sum of complete response rate and partial response rate.
4 secondary outcomes
complete response rate
Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)
1 year progression free survival rate
Time frame: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first （up to 12 months）.
1 year overall survival rate
Time frame: date from diagnosis of NPC to death of any cause (up to 12 months)
safety profiles (including hematologic toxicities and non-hematologic toxicities.)
Time frame: date from diagnosis of NPC to completion of study (about 6 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 20 Apr 2016.
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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.
Liang Wang, DOCTOR principal investigator
Sun Yat-Sen University Cancer Center
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 and Capecitabine in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen 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 5 inclusion and 3 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 20 Apr 2016. 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 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?
overall response rate (time frame: every 4 weeks,up to completion of treatment(approximately 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 20 Apr 2016.