Recurrent Nasopharyngeal CarcinomaPhase 3NCT04215510
Early Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT
A Phase 3 study testing endonasal endoscopic surgery and radiation therapy(IMRT) in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 3 sites in China.
Trial summary
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- endonasal endoscopic surgery and radiation therapy(IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 3 sitesChina
- Study dates
- 1 Mar 2021to 1 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
- Stage T1 or T2 according to AJCC 8th edition ;
- Aged 18 to 70 years;
- Without metastasis;
- previously received 1 course of radiotherapy;
- Without radiotherapy within 1 year, without local treatment for recurrent disease;
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- Surgical resectable and IMRT suitable;
- If regional recurrence presented, regional lesion can be treated with local treatments.
- ECOG score 0 or 1;
- Sufficient organ function;
- Acceptable approach of contraception.
Who cannot join
- Refuse to sign inform consent;
- Radiation encephalopathy or leptomeningeal disease (LMD);
- History of radioactive particle planting;
- Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
- With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
- Any contradiction to surgery;
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- Have any co-existing condition that would preclude full compliance or safety with the study;
- Presence of a significant neurological or psychiatric disease, including dementia and seizures;
- Uncontrolled infectious diseases;
- Female patients who are at pregnancy or lactation.
- Without personal freedom or independent civil capacity.
- With serious autoimmune disease.
- Participants of other interventional clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Fujian Medical University Union Hospital
Fuzhou, Fujian
Desheng Wang, MD
Haichun Lai, MD
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jing Ye, MD
Jing Ye
Fudan University Shanghai cancer center
Shanghai, Shanghai Municipality, 200000
Lin Kong, MD
Jiyi Hu, MD
About this study
Official title: A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Read the detailed description
Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Being tested
- endonasal endoscopic surgery, radiation therapy(IMRT)
- Keywords
- endonasal endoscopic surgery, radiation therapy, 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.
endonasal endoscopic surgeryProcedure or surgery
143 patients will undergo endonasal endoscopic surgery
radiation therapy(IMRT)Radiation
143 patients will undergo radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| endonasal endoscopic surgery group | Experimental | 143 participants in group 1 will undergo endoscopic surgery Receives: Procedure: endonasal endoscopic surgery |
| radiation therapy group | Active comparator | 143 participants in group 2 will undergo radiation therapy(IMRT) Receives: Radiation: radiation therapy(IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year Overall Survival (OS) rate
The proportion of patients who survived 3 years
Measured: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
Secondary outcomes (5)
progression free survival(PFS)
the time from randomization to the first recording of disease progression or death from any cause.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years.
Local progression free survival(LPFS)
the time from randomization to local failure or death
Measured: From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Regional progression free survival(RPFS)
From randomization to regional failure or death
Measured: From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Distant metastasis free survival(DMFS)
From randomization to distant metastasis or death
Measured: From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
toxicities
Using CTCAE Version5.0 to evaluate
Measured: From date of randomization until 3 years after randomization,through study completion,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 posted2 Jan 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Hongmeng Yu, Eye & ENT Hospital of Fudan University
- Investigators
- Hongmeng Yu, MD, Principal investigator, Eye&ENT Hospital,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215510
- Sponsor's protocol ID
- early-rNPC-RCT-01
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2019
- Last updated
- 23 Feb 2021
- 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 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial for Comparing Endonasal Surgery and Radiation Therapy (IMRT) for T1-T2 Recurrent Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04215510
- Acronym / sponsor ID
- early-rNPC-RCT-01
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- endonasal endoscopic surgery, radiation therapy, nasopharyngeal carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Shanghai Municipal Science and Technology Commission
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Jan 2020 (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.
This study is a multicenter RCT to compare 3-year overall survival(OS) rate, progression free survival(PFS),local progression free survival(LPFS),regional progression free survival(RPFS),distant metastasis free survival(DMFS), and toxicities of endonasal endoscopic surgery versus IMRT.
Detailed description
Local and regional recurrence is a common cause of failure after primary radiotherapy for nasopharyngeal carcinoma. Radiotherapy and surgery are the treatments of choice for recurrent NPC. This study aims to compare 3 year overall survival(OS) rate of surgery versus IMRT.A stratified-block randomized approach will be used to randomly assign patients into two treatment groups after stratification according to N staging (N0 vs non-N0). Patients with rNPC will be recruited and randomized into two groups in 1:1 ratio. The primary outcomes will be 3 year overall survival(OS), the secondary outcome measures will be PFS,LPFS,RPFS,DMFS,and toxicities.Assessment will be performed at baseline and during 3 years post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endonasal endoscopic surgery group | Experimental | Procedure: endonasal endoscopic surgery143 participants in group 1 will undergo endoscopic surgery |
| radiation therapy group | Active comparator | Radiation: radiation therapy(IMRT)143 participants in group 2 will undergo radiation therapy(IMRT) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed of recurrent nasopharyngeal carcinoma by pathology or imaging study;
- Stage T1 or T2 according to AJCC 8th edition ;
- Aged 18 to 70 years;
- Without metastasis;
- previously received 1 course of radiotherapy;
Key exclusion criteria (13 listed)
- Refuse to sign inform consent;
- Radiation encephalopathy or leptomeningeal disease (LMD);
- History of radioactive particle planting;
- Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy;
- With prior malignancy (excluding adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer );
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 |
|---|---|---|
| endonasal endoscopic surgery143 patients will undergo endonasal endoscopic surgery | Procedure or surgery | endonasal endoscopic surgery group |
| radiation therapy(IMRT)143 patients will undergo radiation therapy. | Radiation | radiation therapy group |
Primary outcome
3 year Overall Survival (OS) rate
Time frame: From date of randomization until the date of death from any cause,through study completion,up to 3 years.
The proportion of patients who survived 3 years
5 secondary outcomes
progression free survival(PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 3 years.
Local progression free survival(LPFS)
Time frame: From randomization to local failure or date of death from any cause,through study completion,up to 3 years.
Regional progression free survival(RPFS)
Time frame: From randomization to regional failure or date of death from any cause, through study completion,up to 3 years.
Distant metastasis free survival(DMFS)
Time frame: From randomization to distant metastasis or date of death from any cause, through study completion,up to 3 years.
toxicities
Time frame: From date of randomization until 3 years after randomization,through study completion,up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- 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.
Hongmeng Yu, MD principal investigator
Eye&ENT Hospital,Fudan University
3 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 endonasal endoscopic surgery and radiation therapy(IMRT) in people with Recurrent Nasopharyngeal Carcinoma, run by Eye & ENT Hospital of Fudan University at 3 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 11 inclusion and 13 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: opening soon, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaole Song, MD (+86 15821388769, jxfxsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 year Overall Survival (OS) rate (time frame: From date of randomization until the date of death from any cause,through study completion,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 23 Feb 2021.