Nasopharyngeal CarcinomaPhase 3NCT03068936
IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma
A Phase 3 study testing Intensity modulated radiotherapy and Cisplatin in people with Nasopharyngeal Carcinoma, run by Nanfang Hospital, Southern Medical University.
Trial summary
Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Intensity modulated radiotherapy and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Sep 2021
- 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
- The sex of the subject is not limited, the age is from 18 to 70 years old;
- Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
- Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
- Karnofsky score ≥ 80 points;
- No evidence of distant metastasis;
- Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.
Who cannot join
- The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
- Previously received immunotherapy;
- Previously received chemotherapy;
- Previously received radiation therapy;
- Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
- Evidence of distant metastases or other malignancies at the same time.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.
Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intensity modulated radiotherapy, Cisplatin
- Keywords
- Nasopharyngeal Carcinoma, Intensity modulated radiotherapy, Cisplatin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity modulated radiotherapyRadiation
Also called IMRT
Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
CisplatinDrug
Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
| Study group | Role | What they receive |
|---|---|---|
| IMRT group | Experimental | Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy) Receives: Radiation: Intensity modulated radiotherapy |
| IMRT plus cisplatin group | Other | Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times Receives: Radiation: Intensity modulated radiotherapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Refers to the time from included to death due to any cause.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startMar 2017 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2021 (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 Nanfang Hospital, Southern Medical 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
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068936
- Sponsor's protocol ID
- C1033400
- Status last verified
- Sep 2016
- First submitted
- 15 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
- ClinicalTrials.gov ID
- NCT03068936
- Acronym / sponsor ID
- C1033400
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Intensity modulated radiotherapy, Cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 3 Mar 2017 (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.
Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.
Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT group | Experimental | Radiation: Intensity modulated radiotherapyIntensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy) |
| IMRT plus cisplatin group | Other | Radiation: Intensity modulated radiotherapy, Drug: CisplatinIntensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The sex of the subject is not limited, the age is from 18 to 70 years old;
- Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
- Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
- Karnofsky score ≥ 80 points;
- No evidence of distant metastasis;
Key exclusion criteria (6 listed)
- The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
- Previously received immunotherapy;
- Previously received chemotherapy;
- Previously received radiation therapy;
- Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
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 |
|---|---|---|
| Intensity modulated radiotherapyAlso: IMRTIntensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy) | Radiation | IMRT group, IMRT plus cisplatin group |
| CisplatinSynchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times | Drug | IMRT plus cisplatin group |
Primary outcome
Overall survival rate
Time frame: up to 3 years
Refers to the time from included to death due to any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity modulated radiotherapy and Cisplatin in people with Nasopharyngeal Carcinoma, run by Nanfang Hospital, Southern Medical University.
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 6 inclusion and 6 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Dehua Wu (18602062748, 18602062748@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: up to 3 years). 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 3 Mar 2017; AzTrials last refreshed its copy on 1 Nov 2026.