Nasopharyngeal CarcinomaPhase 3NCT05674305
Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy
A Phase 3 study testing Radiotherapy and Cisplatin in people with Nasopharyngeal Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. 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?
- Radiotherapy and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 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
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
- Age 18-70 years.
- Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition).
- Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle.
- ECOG (Eastern Cooperative Oncology Group) score: 0-1
- Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
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- Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN.
- Renal function: serum creatinine <1×ULN.
- Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
Who cannot join
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Receiving radiotherapy or chemotherapy or targeted therapy previously
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- Severe, uncontrolled medical conditions and infections.
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- At the same time using other test drugs or in other clinical trials.
- Refusal or inability to sign informed consent to participate in the trial.
- Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200032
Hongmei Ying, M.D., +8621-64175590 ext. 81400, yinghongmei2011@sina.com
About this study
Official title: A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- 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.
RadiotherapyDrug
IMRT for primary and regional field
CisplatinDrug
Cisplatin 80mg/m2, 21days/cycle, 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy alone | Experimental | Patients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region. Receives: Drug: Radiotherapy |
| Concurrent chemoradiotherapy | Active comparator | Patients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region plus two cycles of concurent chemotherapy （cisplatin 80mg/m2） Receives: Drug: Radiotherapy; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause
Measured: 2 years
Secondary outcomes (3)
Overall survival
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 2 years
Toxicities
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Measured: 2 years
change of quality of life
QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (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 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
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674305
- Sponsor's protocol ID
- 20122229-15
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2022
- Last updated
- 10 Jan 2023
- 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 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05674305
- Acronym / sponsor ID
- 20122229-15
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Jan 2023 (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.
The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy alone | Experimental | Drug: RadiotherapyPatients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region. |
| Concurrent chemoradiotherapy | Active comparator | Drug: Radiotherapy, Drug: CisplatinPatients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region plus two cycles of concurent chemotherapy （cisplatin 80mg/m2） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
- Age 18-70 years.
- Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition).
- Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle.
- ECOG (Eastern Cooperative Oncology Group) score: 0-1
Key exclusion criteria (9 listed)
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Receiving radiotherapy or chemotherapy or targeted therapy previously
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
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 |
|---|---|---|
| RadiotherapyIMRT for primary and regional field | Drug | Concurrent chemoradiotherapy, Radiotherapy alone |
| CisplatinCisplatin 80mg/m2, 21days/cycle, 2 cycles | Drug | Concurrent chemoradiotherapy |
Primary outcome
Progression-free survival
Time frame: 2 years
Defined from date of randomization to date of first documentation of progression or death due to any cause
3 secondary outcomes
Overall survival
Time frame: 2 years
Toxicities
Time frame: 2 years
change of quality of life
Time frame: 1 year
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 10 Jan 2023.
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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.
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 Radiotherapy and Cisplatin in people with Nasopharyngeal Carcinoma, run by Fudan University 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 9 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: looking for participants now, as of the sponsor's last update on 10 Jan 2023. 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?
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 Chengrun Du, MD and PhD (+86-15001733593, duchengrun@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 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 10 Jan 2023.