Nasopharyngeal CarcinomaPhase 3NCT02460419
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
A Phase 3 study testing capecitabine in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy. 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?
- capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Firstly diagnosed metastatic nasopharyngeal carcinoma patients
- Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectation at least 12 weeks
- No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
- With at least one measurable lesion
- Enough blood test
- Signed informed consent
Who cannot join
- Sever heart disease
- HIV infection
- Sever infection
- Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
- Allogeneic organ transplantation
- Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years
Show all 9Show fewer
- Pregnancy or breast feeding
- Difficulty in swallowing
- Received other test drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
Read the detailed description
Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- capecitabine, Best supportive care (BSC)
- Keywords
- Nasopharyngeal carcinoma, metastasis, capecitabine
- Medical subject headings
- Nasopharyngeal Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called Xeloda
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Best supportive care (BSC)Other
Best supportive care and following-up every 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| maintenance capecitabine | Experimental | maintenance capecitabine plus best supportive care(BSC) Receives: Drug: capecitabine; Other: Best supportive care (BSC) |
| best supportive care | Other | Best supportive care and following-up every 6-8 weeks Receives: Other: Best supportive care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
the time from randomization to the progression of disease
Measured: up to 6 years
Secondary outcomes (5)
overall survival
the time from randomization to death
Measured: up to 6 years
duration of response
the time from the date of the first cycle of chemotherapy to the progression of disease
Measured: up to 6 years
objective response rate
CR, PR and SD rate
Measured: up to 6 years
adverse effects
chemotherapy side effects
Measured: up to 6 years
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
evaluate with FACT-H\&N every 3 months after randomiztion
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College
- Responsible party
- Principal investigator, XIANG YANQUN, Sun Yat-sen University
- Investigators
- Xiang Guo, MD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460419
- Sponsor's protocol ID
- 2015029
- Status last verified
- Oct 2022
- First submitted
- 23 May 2015
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin Y, Shi YX, Cai XY, Xia XY, Cai YC, Cao Y, Zhang WD, Hu WH, Jiang WQ. Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. J Cancer Res Clin Oncol. 2012 Oct;138(10):1717-25. doi: 10.1007/s00432-012-1219-x. Epub 2012 Jun 10.
PubMed 22684794Chua DT, Yiu HH, Seetalarom K, Ng AW, Kurnianda J, Shotelersuk K, Krishnan G, Hong RL, Yang MH, Wang CH, Sze WK, Ng WT. Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer. Head Neck. 2012 Sep;34(9):1225-30. doi: 10.1002/hed.21884. Epub 2011 Nov 11.
PubMed 22076785Leong SS, Wee J, Rajan S, Toh CK, Lim WT, Hee SW, Tay MH, Poon D, Tan EH. Triplet combination of gemcitabine, paclitaxel, and carboplatin followed by maintenance 5-fluorouracil and folinic acid in patients with metastatic nasopharyngeal carcinoma. Cancer. 2008 Sep 15;113(6):1332-7. doi: 10.1002/cncr.23687.
PubMed 18615622Han J, Lan X, Tian K, Shen X, He J, Chen N. Cost-effectiveness analysis of capecitabine maintenance therapy plus best supportive care vs. best supportive care alone as first-line treatment of newly diagnosed metastatic nasopharyngeal carcinoma. Front Public Health. 2023 Jan 26;10:1086393. doi: 10.3389/fpubh.2022.1086393. eCollection 2022.
PubMed 36777769Liu GY, Li WZ, Wang DS, Liang H, Lv X, Ye YF, Zhao C, Ke LR, Lv SH, Lu N, Bei WX, Cai ZC, Chen X, Liang CX, Guo X, Xia WX, Xiang YQ. Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):553-561. doi: 10.1001/jamaoncol.2021.7366.
PubMed 35175316
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
- ClinicalTrials.gov ID
- NCT02460419
- Acronym / sponsor ID
- 2015029
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, metastasis, capecitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College
- Study start
- Apr 2015
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 2 Jun 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.
This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
Detailed description
Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maintenance capecitabine | Experimental | Drug: capecitabine, Other: Best supportive care (BSC)maintenance capecitabine plus best supportive care(BSC) |
| best supportive care | Other | Other: Best supportive care (BSC)Best supportive care and following-up every 6-8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Firstly diagnosed metastatic nasopharyngeal carcinoma patients
- Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Life expectation at least 12 weeks
- No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
Key exclusion criteria (9 listed)
- Sever heart disease
- HIV infection
- Sever infection
- Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
- Allogeneic organ transplantation
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 |
|---|---|---|
| capecitabineAlso: Xelodacapecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops. | Drug | maintenance capecitabine |
| Best supportive care (BSC)Best supportive care and following-up every 6-8 weeks | Other | best supportive care, maintenance capecitabine |
Primary outcome
progression-free survival
Time frame: up to 6 years
the time from randomization to the progression of disease
5 secondary outcomes
overall survival
Time frame: up to 6 years
duration of response
Time frame: up to 6 years
objective response rate
Time frame: up to 6 years
adverse effects
Time frame: up to 6 years
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
Time frame: up to 6 years
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 28 Oct 2022.
- Background: PubMed 22684794Jin Y, Shi YX, Cai XY, Xia XY, Cai YC, Cao Y, Zhang WD, Hu WH, Jiang WQ. Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. J Cancer Res Clin Oncol. 2012 Oct;138(10):1717-25. doi: 10.1007/s00432-012-1219-x. Epub 2012 Jun 10.
- Background: PubMed 22076785Chua DT, Yiu HH, Seetalarom K, Ng AW, Kurnianda J, Shotelersuk K, Krishnan G, Hong RL, Yang MH, Wang CH, Sze WK, Ng WT. Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer. Head Neck. 2012 Sep;34(9):1225-30. doi: 10.1002/hed.21884. Epub 2011 Nov 11.
- Background: PubMed 18615622Leong SS, Wee J, Rajan S, Toh CK, Lim WT, Hee SW, Tay MH, Poon D, Tan EH. Triplet combination of gemcitabine, paclitaxel, and carboplatin followed by maintenance 5-fluorouracil and folinic acid in patients with metastatic nasopharyngeal carcinoma. Cancer. 2008 Sep 15;113(6):1332-7. doi: 10.1002/cncr.23687.
- Derived from this study: PubMed 36777769Han J, Lan X, Tian K, Shen X, He J, Chen N. Cost-effectiveness analysis of capecitabine maintenance therapy plus best supportive care vs. best supportive care alone as first-line treatment of newly diagnosed metastatic nasopharyngeal carcinoma. Front Public Health. 2023 Jan 26;10:1086393. doi: 10.3389/fpubh.2022.1086393. eCollection 2022.
- Derived from this study: PubMed 35175316Liu GY, Li WZ, Wang DS, Liang H, Lv X, Ye YF, Zhao C, Ke LR, Lv SH, Lu N, Bei WX, Cai ZC, Chen X, Liang CX, Guo X, Xia WX, Xiang YQ. Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):553-561. doi: 10.1001/jamaoncol.2021.7366.
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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.
Xiang Guo, MD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing capecitabine in people with Nasopharyngeal Carcinoma, 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 8 inclusion and 9 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 28 Oct 2022. 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 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?
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?
progression-free survival (time frame: up to 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02460419, which also lists 5 linked publications.
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 28 Oct 2022.