Nasopharyngeal CarcinomaPhase 3NCT04061278
A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients
A Phase 3 study testing 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy and 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma and Neoadjuvant Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 12 sites in China.
Trial summary
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy
- What is being tested?
- 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy and 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 12 sitesChina
- Study dates
- 1 Aug 2019to 31 Dec 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
- Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
- According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
- Patients who have not received disease-related anti-tumor system therapy;
- Age 18~70 years;
- Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
- Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
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- Cartesian score ≥70; or ECOG PS 0 or 1
- Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
- Sign the informed consent.
Who cannot join
- Patients with distant metastases were identified at the time of diagnosis;
- Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
- Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
- Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
- A woman who is pregnant or lactating;
- Known active HIV or HBV, HCV infection;
- Known to be allergic to drugs that may be used;
- The researchers did not consider participants to be eligible for this study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Benhua Xu
- Not yet recruiting
Cancer prevention and treatment center, sun yat-sen university
Guandong, Guangdong, 510060
Yuanhong Gao
- Not yet recruiting
The first affiliated hospital, college of medicinle, Zhejiang University
Hangzhou, Zhejiang, 310009
Senxiang Yan
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310009
Xiaozhong Chen
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310009
Yongshi Jia
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310058
Zexin Chen, +86 0571 87783759, keyanlunli_zheer@163.com
- Not yet recruiting
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, 311200
Guoping Han
- Not yet recruiting
Jinhua Central Hospital
Jinhua, Zhejiang, 321000
Wangyuan Hu
- Not yet recruiting
Lishui City Central Hospital
Lishui, Zhejiang, 323000
Dexi Du
- Not yet recruiting
Ningbo Yinzhou People's Hospital
Ningbo, Zhejiang, 315000
Jun Chen
- Not yet recruiting
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315010
Chuangzhou Rao
- Not yet recruiting
People's Hospital of Quzhou
Quzhou, Zhejiang, 324000
Huijuan He
About this study
Official title: A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.
- Conditions
- Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy
- Being tested
- 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy
- Keywords
- Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy, Concurrent 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.
4 cycles of Neoadjuvant Chemotherapy With Definitive RadiotherapyDrug
4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapyDrug
3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy | Experimental | Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy Receives: Drug: 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy |
| 3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy | Active comparator | 3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy Receives: Drug: 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
the duration between the date of diagnosed and date of patient death
Measured: 5 years
5-year metastatic free survival
the duration between the date of diagnosed and date of metastasis
Measured: 5 years
Secondary outcomes (3)
5-year disease-free survival
the duration between the date of diagnosed and date of related disease
Measured: 5 years
5-year recurrence-free survival
the duration between the date of diagnosed and date of recurrence
Measured: 5 years
Safety (incidence of grade 3/4 adverse reactions)
treatment related toxic effects
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Aug 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 246 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qichun Wei, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061278
- Sponsor's protocol ID
- SAHZhejiangU-2019-009
- Status last verified
- Aug 2019
- First submitted
- 13 Aug 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04061278
- Acronym / sponsor ID
- SAHZhejiangU-2019-009
- Conditions
- Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy
- Keywords
- Nasopharyngeal Carcinoma, Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Aug 2019 (actual)
- 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.
At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy | Experimental | Drug: 4 cycles of Neoadjuvant Chemotherapy With Definitive RadiotherapyFour cycles of neoadjuvant chemotherapy combined with radical radiotherapy |
| 3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy | Active comparator | Drug: 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
- According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
- Patients who have not received disease-related anti-tumor system therapy;
- Age 18~70 years;
- Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
Key exclusion criteria (8 listed)
- Patients with distant metastases were identified at the time of diagnosis;
- Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
- Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
- Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
- A woman who is pregnant or lactating;
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 |
|---|---|---|
| 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy | Drug | 4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy |
| 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy | Drug | 3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy |
Primary outcome
5-year overall survival
Time frame: 5 years
the duration between the date of diagnosed and date of patient death
5-year metastatic free survival
Time frame: 5 years
the duration between the date of diagnosed and date of metastasis
3 secondary outcomes
5-year disease-free survival
Time frame: 5 years
5-year recurrence-free survival
Time frame: 5 years
Safety (incidence of grade 3/4 adverse reactions)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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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.
Qichun Wei study chair
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy and 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy in people with Nasopharyngeal Carcinoma and Neoadjuvant Chemotherapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 12 sites 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 9 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 Qichun Wei (0571-87783522, qichun_wei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 12 May 2020.