Local Advanced High Risk Nasopharyngeal CarcinomaPhase 3NCT02143388
Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
A Phase 3 study testing IMRT combine with cisplatin concurrent chemotherapy and IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy in people with Local Advanced High Risk Nasopharyngeal Carcinoma, run by Zhao Chong at 1 site in China.
Trial summary
This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Local Advanced High Risk Nasopharyngeal Carcinoma
- What is being tested?
- IMRT combine with cisplatin concurrent chemotherapy and IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2014to 5 Aug 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- Clinical stage III~IVb(UICC 7th)
- Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
- Range from 18～70 years old
- WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
- OSerum creatinine < 1.5×ULN
Who cannot join
- Central nervous system metastases
- Suitable for local treatment
- Uncontrolled seizure disorder or other serious neurologic disease
- Clinically significant cardiac or respiratory disease
- Drug or alcohol addition
- Do not have full capacity for civil acts
Show all 9Show fewer
- Severe complication, active infection
- Concurrent immunotherapy or hormone therapy for other diseases
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
- Being tested
- IMRT combine with cisplatin concurrent chemotherapy, IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- Keywords
- Local advanced, high risk, nasopharyngeal carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT combine with cisplatin concurrent chemotherapyDrug
Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapyDrug
Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemoradiation + adjuvant chemotherapy | Experimental | IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy Receives: Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy |
| Concurrent chemoradiation | Active comparator | IMRT combine with cisplatin concurrent chemotherapy Receives: Drug: IMRT combine with cisplatin concurrent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Measured: 3-year
Secondary outcomes (1)
Acute Toxicity
To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study start31 Mar 2014
- Primary completion27 Jul 2018
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Local Advanced High Risk 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhao Chong
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, Singapore
- Responsible party
- Sponsor-investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- zhao chong, M.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143388
- Sponsor's protocol ID
- CCRT-AC-LAHR-NPC
- Status last verified
- Aug 2022
- First submitted
- 7 May 2014
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu Y, Yan W, Chen Y, Miao J, Zhang H, Wang J, Zhang Y, Huang X, Wang K, Qu Y, Chen X, Zhang J, Luo J, Li YX, Zhao C, Ma J, Wu R, Yi J. Treatment response-adapted risk index model for survival prediction and adjuvant chemotherapy selection in nonmetastatic nasopharyngeal carcinoma. NPJ Digit Med. 2025 Sep 1;8(1):564. doi: 10.1038/s41746-025-01918-2.
PubMed 40890288Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.
PubMed 36227615
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT02143388
- Acronym / sponsor ID
- CCRT-AC-LAHR-NPC
- Keywords
- Local advanced, high risk, nasopharyngeal carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Zhao ChongUniversity, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, Singapore
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 21 May 2014 (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 is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemoradiation + adjuvant chemotherapy | Experimental | Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapyIMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy |
| Concurrent chemoradiation | Active comparator | Drug: IMRT combine with cisplatin concurrent chemotherapyIMRT combine with cisplatin concurrent chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- Clinical stage III~IVb(UICC 7th)
- Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
- Range from 18～70 years old
- WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
Key exclusion criteria (9 listed)
- Central nervous system metastases
- Suitable for local treatment
- Uncontrolled seizure disorder or other serious neurologic disease
- Clinically significant cardiac or respiratory disease
- Drug or alcohol addition
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 |
|---|---|---|
| IMRT combine with cisplatin concurrent chemotherapyPatients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT. | Drug | Concurrent chemoradiation |
| IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapyPatients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles. | Drug | Concurrent chemoradiation + adjuvant chemotherapy |
Primary outcome
Failure free survival
Time frame: 3-year
Defined as the time from date of recruitment to documented relapse or death from any cause.
1 secondary outcome
Acute Toxicity
Time frame: 18 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 31 Aug 2022.
- Derived from this study: PubMed 40890288Liu Y, Yan W, Chen Y, Miao J, Zhang H, Wang J, Zhang Y, Huang X, Wang K, Qu Y, Chen X, Zhang J, Luo J, Li YX, Zhao C, Ma J, Wu R, Yi J. Treatment response-adapted risk index model for survival prediction and adjuvant chemotherapy selection in nonmetastatic nasopharyngeal carcinoma. NPJ Digit Med. 2025 Sep 1;8(1):564. doi: 10.1038/s41746-025-01918-2.
- Derived from this study: PubMed 36227615Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.
- Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
Related trials for Local Advanced High Risk Nasopharyngeal Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma
Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma
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.
zhao chong, M.D principal investigator
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 IMRT combine with cisplatin concurrent chemotherapy and IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy in people with Local Advanced High Risk Nasopharyngeal Carcinoma, run by Zhao Chong 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 7 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 31 Aug 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?
Failure free survival (time frame: 3-year). 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 NCT02143388, which also lists 2 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 31 Aug 2022.