Nasopharyngeal CarcinomaPhase 3OARTNCT06516133
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
A Phase 3 study testing Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Chemotherapy and Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. 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 radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Chemotherapy and Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2024to Dec 2030
- 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
- Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
- No evidence of distant metastasis (M0).
- Age between 18 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
- Undergoing radical intensity-modulated radiation therapy (IMRT).
- No claustrophobia and able to remain in a fixed position for at least 30 minutes
- Patients must be informed of the main content of this study, sign an informed consent form, and be willing and able to comply with the treatment, follow-up plan, laboratory tests, and other requirements specified in the study protocol.
Who cannot join
- Histological types include squamous cell carcinoma or basal cell carcinoma.
- Radiation therapy intended for palliative care.
- History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
- Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
- Previous radical radiotherapy for nasopharyngeal cancer.
- Primary and neck metastatic lesions treated with chemotherapy or surgery.
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- Presence of other serious underlying diseases that may pose a greater risk or affect compliance with the trial. Examples include unstable cardiac diseases requiring treatment, renal diseases, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5×ULN), and psychiatric disorders.
- Initial assessment of treatment efficacy more than 120 days after the end of radiotherapy.
- Inability to undergo enhanced magnetic resonance imaging due to contrast agent allergies, claustrophobia.
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yu-xian Yang, +86 147 4892 2370, yangyx1@sysucc.org.cn
Guan-quan Zhou, +86 159 1437 2887, zhougq@sysucc.org.cn
About this study
Official title: Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Chemotherapy, Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy
- Keywords
- Nasopharyngeal Carcinoma, Online adaptive radiotherapy, Smaller PTV margin
- 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 radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapyRadiation
Radiation: Complete the full course of radiotherapy using the original treatment plan.
Planning target volume (PTV) margin: 3mm;
ChemotherapyDrug
Chemotherapy: If given, platinum-based.
Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapyRadiation
Radiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients.
planning target volume (PTV) margin: smaller.
ChemotherapyDrug
Chemotherapy: If given, platinum-based
| Study group | Role | What they receive |
|---|---|---|
| Conventional radiotherapy with conventional margins w or w/o chemotherapy | Active comparator | Complete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm. Receives: Radiation: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy; Drug: Chemotherapy |
| Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy | Experimental | Throughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients.
PTV margin: smaller. Receives: Radiation: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence-free survival
locoregional progression free survival
Measured: 3-year
Secondary outcomes (6)
Overall survival
overall survival
Measured: 3-year
Distant metastasis free survival
Distant metastasis free survival
Measured: 3-year
Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Acute radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Measured: 3 months
Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Late radiation-induced events. The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Measured: 3-year
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)
The minimum and maximum values are 0 and 4 respectively. The higher scores mean a worse outcome.
Measured: From baseline to 3 years post-radiotherapy
and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)
The minimum and maximum values are 0 and 5 respectively. The higher scores mean a worse outcome.
Measured: From baseline to 3 years post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start17 May 2024
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (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 Sun Yat-sen 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
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YingSun, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516133
- Sponsor's protocol ID
- SL-B2023-685-02
- Acronym
- OART
- Status last verified
- Jul 2024
- First submitted
- 27 Dec 2023
- Last updated
- 23 Jul 2024
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial
- ClinicalTrials.gov ID
- NCT06516133
- Acronym / sponsor ID
- OART / SL-B2023-685-02
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, Online adaptive radiotherapy, Smaller PTV margin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Jul 2024 (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.
In this multicenter, prospective, randomized, controlled, non-inferiority Phase III clinical trial, treatment-naïve patients with nasopharyngeal carcinoma (NPC) without metastasis will be enrolled for curative radiotherapy. The participants will be randomly assigned to two groups. The experimental group will receive online adaptive radiotherapy (ART) during the radiotherapy process, with a smaller PTV margin, while the control group will use original treatment plan during full-course radiotherapy, with a PTV margin of 3 mm. The study aims to compare the survival, adverse events, and quality of survival between the two groups, with the primary endpoint being the locoregional recurrence-free survival rate. The main objective is to determine the role of online ART in nasopharyngeal carcinoma, elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional radiotherapy with conventional margins w or w/o chemotherapy | Active comparator | Radiation: Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Drug: ChemotherapyComplete the full course of radiotherapy using the original treatment plan. PTV margin: 3mm. |
| Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy | Experimental | Radiation: Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy, Drug: ChemotherapyThroughout the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of the patients. PTV margin: smaller. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed nasopharyngeal carcinoma confirmed by pathology, with a histological classification of non-keratinizing carcinoma (according to the World Health Organization, WHO), pathological classification.
- No evidence of distant metastasis (M0).
- Age between 18 and 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score:0-1.
- Undergoing radical intensity-modulated radiation therapy (IMRT).
Key exclusion criteria (9 listed)
- Histological types include squamous cell carcinoma or basal cell carcinoma.
- Radiation therapy intended for palliative care.
- History of malignant tumors, excluding adequately treated basal cell carcinoma, squamous cell carcinoma, and cervical intraepithelial neoplasia.
- Pregnant or lactating women (women of childbearing age should undergo pregnancy testing; effective contraception should be emphasized during treatment.
- Previous radical radiotherapy for nasopharyngeal 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 |
|---|---|---|
| Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapyRadiation: Complete the full course of radiotherapy using the original treatment plan. Planning target volume (PTV) margin: 3mm; | Radiation | Conventional radiotherapy with conventional margins w or w/o chemotherapy |
| ChemotherapyChemotherapy: If given, platinum-based. | Drug | Conventional radiotherapy with conventional margins w or w/o chemotherapy |
| Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapyRadiation: During the course of radiotherapy, the treatment plan is adjusted online based on the anatomical and dosimetric changes in the target volumes and organs at risk of patients. planning target volume (PTV) margin: smaller. | Radiation | Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy |
| ChemotherapyChemotherapy: If given, platinum-based | Drug | Radiotherapy with smaller margin and online adaptive radiotherapy w or w/o chemotherapy |
Primary outcome
Locoregional recurrence-free survival
Time frame: 3-year
locoregional progression free survival
6 secondary outcomes
Overall survival
Time frame: 3-year
Distant metastasis free survival
Time frame: 3-year
Rate of acute radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0)
Time frame: 3 months
Rate of late radiation-induced events according to Common Terminology Criteria for Adverse Events (CTCAE 5.0).
Time frame: 3-year
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 Version 1.0 (EORTC QLQ-HN35 V1.0)
Time frame: From baseline to 3 years post-radiotherapy
and National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events Version 1.0 (NCI-PRO-CTCAE V1.0.)
Time frame: From baseline to 3 years post-radiotherapy
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 Jul 2024.
- 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.
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 Intensity modulated radiation therapy (IMRT) with conventional planning target volume (PTV) margin and without online adaptive radiotherapy, Chemotherapy and Intensity modulated radiation therapy (IMRT) with smaller planning target volume (PTV) margin and online adaptive radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen 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 7 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 23 Jul 2024. 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 Yu-xian Yang, MD (+86 147 4892 2370, yangyx1@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence-free survival (time frame: 3-year). 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 Jul 2024.