Locally Advanced Nasopharyngeal CarcinomaPhase 3IRCNPCNCT03015727
Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
A Phase 3 study testing Docetaxel, Cisplatin and IMRT/TOMO in people with Locally Advanced Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Locally Advanced Nasopharyngeal Carcinoma
- What is being tested?
- Docetaxel, Cisplatin and IMRT/TOMO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2024
- 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
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
- No evidence of distant metastasis (M0)
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
- Renal: creatinine clearance >60ml/min
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- Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
- With controlled blood glucose for diabetes patients
- Written informed consent
- satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
Who cannot join
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >65 or <18
- With a history of renal disease
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
- Peripheral neuropathy
- Emotional disturbance
Trial locations and contacts
1 site in 1 country.
Xiaozhong Chen contact
China1 site, 1 recruiting
- Recruiting
Xiaozhong Chen
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, +86-571-88128202, cxzfyun@sina.com
About this study
Official title: Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
Read the detailed description
In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
- Keywords
- nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called DOC
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
CisplatinDrug
Also called DDP
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
IMRT/TOMORadiation
intensity modulated radiation therapy or tomotherapy
ChemotherapyDrug
Also called concurrent chemotherapy
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| IC+RT group | Experimental | 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy. Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: IMRT/TOMO |
| IC+CCRT group | Active comparator | 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2. Receives: Drug: Docetaxel; Drug: Cisplatin; Radiation: IMRT/TOMO; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival (PFS)
PFS means assignment to the date of any local or distant progress of the disease.
Measured: 3 years after the inception assignment
Secondary outcomes (2)
Overall Survival (OS)
The overall survival denote to assignment to date of death from any cause.
Measured: 3 years and 5 years after the inception of the assignment
Adverse Events
Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The Central Hospital of Lishui City, Jinhua Central Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, People's Hospital of Quzhou
- Responsible party
- Sponsor
- Investigators
- Xiaozhong Chen, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015727
- Sponsor's protocol ID
- ZhejiangCH 01536224
- Acronym
- IRCNPC
- Status last verified
- Dec 2016
- First submitted
- 24 Dec 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Jin T, Jiang F, Jin QF, Hua YH, Jia YS, Du DX, Ding SB, Su HF, Lu MZ, He HJ, Chen XZ. Randomized, multicenter phase 3 study evaluating radiotherapy versus concurrent chemoradiotherapy in nasopharyngeal carcinoma patients achieving CR/PR after induction chemotherapy. BMC Med. 2026 Jul 11. doi: 10.1186/s12916-026-05064-8. Online ahead of print.
PubMed 42436536
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03015727
- Acronym / sponsor ID
- IRCNPC / ZhejiangCH 01536224
- Keywords
- nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital, The Central Hospital of Lishui City, Jinhua Central Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, People's Hospital of Quzhou
- Study start
- Dec 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Jan 2017 (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.
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
Detailed description
In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IC+RT group | Experimental | Drug: Docetaxel, Drug: Cisplatin, Radiation: IMRT/TOMO3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy. |
| IC+CCRT group | Active comparator | Drug: Docetaxel, Drug: Cisplatin, Radiation: IMRT/TOMO, Drug: Chemotherapy3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
- No evidence of distant metastasis (M0)
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
Key exclusion criteria (8 listed)
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >65 or <18
- With a history of renal disease
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
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: DOC3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2. | Drug | IC+CCRT group, IC+RT group |
| CisplatinAlso: DDP3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2. | Drug | IC+CCRT group, IC+RT group |
| IMRT/TOMOintensity modulated radiation therapy or tomotherapy | Radiation | IC+CCRT group, IC+RT group |
| ChemotherapyAlso: concurrent chemotherapy2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2. | Drug | IC+CCRT group |
Primary outcome
Progress Free Survival (PFS)
Time frame: 3 years after the inception assignment
PFS means assignment to the date of any local or distant progress of the disease.
2 secondary outcomes
Overall Survival (OS)
Time frame: 3 years and 5 years after the inception of the assignment
Adverse Events
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 42436536Jin T, Jiang F, Jin QF, Hua YH, Jia YS, Du DX, Ding SB, Su HF, Lu MZ, He HJ, Chen XZ. Randomized, multicenter phase 3 study evaluating radiotherapy versus concurrent chemoradiotherapy in nasopharyngeal carcinoma patients achieving CR/PR after induction chemotherapy. BMC Med. 2026 Jul 11. doi: 10.1186/s12916-026-05064-8. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Xiaozhong Chen contact
Xiaozhong Chen study chair
Zhejiang Cancer Hospital
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 Docetaxel, Cisplatin and IMRT/TOMO in people with Locally Advanced Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital 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 10 inclusion and 8 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 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaozhong Chen (cxzfyun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (PFS) (time frame: 3 years after the inception assignment). 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 NCT03015727, which also lists 1 linked publication.
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 Jan 2017.