Local Advanced High Risk Nasopharyngeal CarcinomaPhase 3NCT02973386

Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

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 Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 294 participants
Where: 1 siteChina
Study dates: 13 Jan 2017to Dec 2025
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/AJCC 7th)
No distant metastasis
Karnofsky Performance Status Scale≥70
WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
Sign the informed consent.

Who cannot join

Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
Younger than 18 years old or older than 70 years old
Are receiving other drugs treanment
kidney disease
Have suffered from other tumor or now suffering from other tumor
Have recieved chemotherapy or radiotherapy

Show all 9Show fewer

Pregnancy or lactation
unstable heart disease need timely treatment
Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong

Other trials in China

About this study

Official title: Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis

This is a randomized,controlled,prospective phase III 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 Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.

Conditions: 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 and day 22) 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 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.

Study groups in NCT02973386
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.

Distant metastasis-free survival
Defined as the time from date of recruitment to documented distant metastasis or death from any cause.
Measured: Five year

Secondary outcomes (5)

Failure-free survival
Defined as the time from date of recruitment to documented relapse or death from any cause.
Measured: Five year
Locoregional relapse-free survival
Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.
Measured: Five year
Overall survival
Defined as the time from date of recruitment to death from any cause.
Measured: Five year
Acute toxicity
Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities.
Measured: three months after corresponding treatment
Late toxicity
Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria.
Measured: Five year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 2017Dec 2025

First posted25 Nov 2016 (estimated)
Study start13 Jan 2017
Primary completion25 Oct 2022
Study completionDec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Local Advanced High Risk 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: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02973386
Sponsor's protocol ID: CCRT-AC-HRDM-NPC
Status last verified: May 2026
First submitted: 22 Nov 2016
Last updated: 7 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis
ClinicalTrials.gov ID: NCT02973386
Acronym / sponsor ID: CCRT-AC-HRDM-NPC
Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
Keywords: Local advanced, High Risk, Nasopharyngeal Carcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 13 Jan 2017 (actual)
Primary completion: 25 Oct 2022 (actual)
Study completion: Dec 2025 (actual)
First posted: 25 Nov 2016 (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.

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/AJCC 7th)
No distant metastasis
Karnofsky Performance Status Scale≥70
WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L

Key exclusion criteria (9 listed)

Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
Younger than 18 years old or older than 70 years old
Are receiving other drugs treanment
kidney disease
Have suffered from other tumor or now suffering from other tumor

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 and day 22) 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 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.	Drug	Concurrent chemoradiation + adjuvant chemotherapy

Primary outcome

Distant metastasis-free survival
Time frame: Five year
Defined as the time from date of recruitment to documented distant metastasis or death from any cause.

5 secondary outcomes

Failure-free survival
Time frame: Five year
Locoregional relapse-free survival
Time frame: Five year
Overall survival
Time frame: Five year
Acute toxicity
Time frame: three months after corresponding treatment
Late toxicity
Time frame: Five year

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 7 May 2026.
Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.

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 Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 May 2026. 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?

Distant metastasis-free survival (time frame: Five 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 NCT02973386.

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 7 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.