NPC PatientsIMPRINTNCT07232680
Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy
An observational study of NPC Patients and Nasopharyngeal Cancinoma (NPC), run by Cheng-En Hsieh at 1 site in Taiwan.
Trial summary
To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NPC Patients, Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Proton chemoradiotherapy and Photon chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2025to 15 Aug 2034
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AJCC 9th edition stage I-III nasopharyngeal carcinoma undergoing definitive chemoradiotherapy using either proton or photon radiotherapy.
Who may be able to join
- Willingness to provide written informed consent.
- Pathologically confirmed diagnosis of nasopharyngeal carcinoma
- Age ≥18 years
- ECOG performance status 0-1
- Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy
- Adequate bone marrow, liver, and renal function within 4 weeks before study registration
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- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1,000/mm3
- Platelet count ≥ 50,000/μL
- Total bilirubin < 2.5 mg/dL
- Serum albumin >2.8 g/dL
- Serum creatinine ≤ 1.5 mg/dL
Who cannot join
- Presence of distant metastasis
- Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone.
- Synchronous or prior invasive malignancy, unless disease-free for at least 2 years.
- Prior radiotherapy to the head and neck region
- Presence of severe major organ dysfunction
- Pregnant women or women of childbearing potential who are unwilling to use medically acceptable contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital at Linkou
Taoyuan City, Taiwan, 333
Cheng-En Hsieh, MD, PhD, +886-3-328-1200 ext. 7000, rodney445@gmail.com
About this study
Official title: Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy
To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.
Read the detailed description
This is a non-randomized, single-center, phase II prospective trial enrolling patients with stage I-III NPC undergoing definitive proton or photon chemoradiotherapy. Participants will be followed for ≥2 years after treatment completion to evaluate clinical outcomes and longitudinal biomarker dynamics, including radiomic and immunologic signatures.
Radiotherapy target delineation was performed according to established consensus guidelines. The gross tumor volume (GTV) included all radiologically visible primary tumors and involved lymph nodes. The clinical target volume receiving 69.96 Gy encompassed the GTV with a 0-5 mm margin and may also include the entire nasopharynx. The clinical target volume receiving 59.4 Gy was optionally delineated at the discretion of the treating physician to encompass regions at high risk for microscopic disease spread, including the nasopharynx, nasal cavity, maxillary sinuses, pterygoid plates, parapharyngeal space, retropharyngeal lymph nodes, clivus, skull base, sphenoid sinus, and bilateral upper cervical lymph nodes. The elective neck volumes, receiving 50-54.12 Gy , encompassed the bilateral cervical lymphatic drainage regions. The detailed contour definitions followed the International Consensus Guidelines on Delineation of Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma.
Concurrent Chemotherapy Regimens:
- Cisplatin Based Regimens
- Dosage: Cisplatin 100 mg/m² IV on Day 1 every 3 weeks during radiotherapy (total 2-3 cycles); Cisplatin 50 mg/m² IV on Day 1 every 2 weeks during radiotherapy (typically 6-8 weeks); Cisplatin 40 mg/m² IV weekly during radiotherapy (typically 6-7 weeks)
- Carboplatin-Based Regimens o Dosage: Carboplatin AUC 5-6 IV every 3 weeks
The use of induction chemotherapy is allowed in locally advanced NPC
- TPF Regimen (Docetaxel + Cisplatin + 5-Fluorouracil)
- Docetaxel: 75 mg/m² IV on Day 1
- Cisplatin: 75 mg/m² IV on Day 1
- 5-FU: 750-1000 mg/m²/day continuous IV infusion on Days 1-5
- Cycle: Every 3 weeks × 2-3 cycles
- GP Regimen (Gemcitabine + Cisplatin)
- Gemcitabine: 1000 mg/m² IV on Days 1 and 8
- Cisplatin: 80 mg/m² IV on Day 1
- Cycle: Every 3 weeks × 2-3 cycles
- TP Regimen (Docetaxel + Cisplatin)
- Docetaxel: 75 mg/m² IV on Day 1
- Cisplatin: 75 mg/m² IV on Day 1
- Cycle: Every 3 weeks × 2-3 cycles
- Conditions
- NPC Patients, Nasopharyngeal Cancinoma (NPC)
- Being tested
- Proton chemoradiotherapy, Photon chemoradiotherapy
- Keywords
- NPC, proton radiotherapy, photon radiotherapy, proton beam therapy, IMPT, IMRT, IMAT, chemoradiation, Immune response, Radiomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton chemoradiotherapyRadiation
Concurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions.
Photon chemoradiotherapyRadiation
Concurrent chemoradiotherapy will be delivered using photon-based volumetric modulated arc therapy, with a total dose of 69.96 Gy administered in 33 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Proton chemoradiotherapy | Proton chemoradiotherapy: 69.96 cobalt Gray equivalent (CGE) in 33 fractions Receives: Radiation: Proton chemoradiotherapy | |
| Photon chemoradiotherapy | Photon chemoradiotherapy: 69.96 Gy in 33 fractions Receives: Radiation: Photon chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is defined as the time from signing the informed consent to death from any cause.
Measured: 2 years
Secondary outcomes (3)
Progression free survival
Progression free survival is defined as the time from signing the informed consent to the first occurrence of disease progression or death from any cause (whichever occurs first) according to RECIST1.1
Measured: 2 years
Time to progression
Time to progression is defined as the time from signing the informed consent to the first occurrence of disease progression according to RECIST1.1.
Measured: 2 years
Incidence and severity of adverse events
Acute and late adverse events will be graded using CTCAE v5
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 posted18 Nov 2025
- Study start20 Nov 2025
- Primary completion15 Aug 2031 (estimated)
- Study completion15 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NPC PatientsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-En Hsieh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cheng-En Hsieh, Chang Gung Memorial Hospital
- Investigators
- Rodney Cheng En Hsieh, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232680
- Sponsor's protocol ID
- 202501031A3
- Acronym
- IMPRINT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The sharing of individual participant data (IPD) will be conducted only after obtaining approval from the Institutional Review Board (IRB) and in accordance with applicable ethical and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Prospective Analysis of Radiomic and Immunologic Signatures in Nasopharyngeal Carcinoma Treated With Proton or Photon Radiotherapy
- ClinicalTrials.gov ID
- NCT07232680
- Acronym / sponsor ID
- IMPRINT / 202501031A3
- Conditions
- NPC Patients, Nasopharyngeal Cancinoma (NPC)
- Keywords
- NPC, proton radiotherapy, photon radiotherapy, proton beam therapy, IMPT, IMRT, IMAT, chemoradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cheng-En HsiehUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 15 Aug 2031 (estimated)
- Study completion
- 15 Aug 2034 (estimated)
- First posted
- 18 Nov 2025 (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.
To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.
Detailed description
This is a non-randomized, single-center, phase II prospective trial enrolling patients with stage I-III NPC undergoing definitive proton or photon chemoradiotherapy. Participants will be followed for ≥2 years after treatment completion to evaluate clinical outcomes and longitudinal biomarker dynamics, including radiomic and immunologic signatures.
Radiotherapy target delineation was performed according to established consensus guidelines. The gross tumor volume (GTV) included all radiologically visible primary tumors and involved lymph nodes. The clinical target volume receiving 69.96 Gy encompassed the GTV with a 0-5 mm margin and may also include the entire nasopharynx. The clinical target volume receiving 59.4 Gy was optionally delineated at the discretion of the treating physician to encompass regions at high risk for microscopic disease spread, including the nasopharynx, nasal cavity, maxillary sinuses, pterygoid plates, parapharyngeal space, retropharyngeal lymph nodes, clivus, skull base, sphenoid sinus, and bilateral upper cervical lymph nodes. The elective neck volumes, receiving 50-54.12 Gy , encompassed the bilateral cervical lymphatic drainage regions. The detailed contour definitions followed the International Consensus Guidelines on Delineation of Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma.
Concurrent Chemotherapy Regimens:
- Cisplatin Based Regimens
- Dosage: Cisplatin 100 mg/m² IV on Day 1 every 3 weeks during radiotherapy (total 2-3 cycles); Cisplatin 50 mg/m² IV on Day 1 every 2 weeks during radiotherapy (typically 6-8 weeks); Cisplatin 40 mg/m² IV weekly during radiotherapy (typically 6-7 weeks)
- Carboplatin-Based Regimens o Dosage: Carboplatin AUC 5-6 IV every 3 weeks
The use of induction chemotherapy is allowed in locally advanced NPC
- TPF Regimen (Docetaxel + Cisplatin + 5-Fluorouracil)
- Docetaxel: 75 mg/m² IV on Day 1
- Cisplatin: 75 mg/m² IV on Day 1
- 5-FU: 750-1000 mg/m²/day continuous IV infusion on Days 1-5
- Cycle: Every 3 weeks × 2-3 cycles
- GP Regimen (Gemcitabine + Cisplatin)
- Gemcitabine: 1000 mg/m² IV on Days 1 and 8
- Cisplatin: 80 mg/m² IV on Day 1
- Cycle: Every 3 weeks × 2-3 cycles
- TP Regimen (Docetaxel + Cisplatin)
- Docetaxel: 75 mg/m² IV on Day 1
- Cisplatin: 75 mg/m² IV on Day 1
- Cycle: Every 3 weeks × 2-3 cycles
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton chemoradiotherapy | – | Radiation: Proton chemoradiotherapyProton chemoradiotherapy: 69.96 cobalt Gray equivalent (CGE) in 33 fractions |
| Photon chemoradiotherapy | – | Radiation: Photon chemoradiotherapyPhoton chemoradiotherapy: 69.96 Gy in 33 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AJCC 9th edition stage I-III nasopharyngeal carcinoma undergoing definitive chemoradiotherapy using either proton or photon radiotherapy.
Key inclusion criteria (12 listed)
- Willingness to provide written informed consent.
- Pathologically confirmed diagnosis of nasopharyngeal carcinoma
- Age ≥18 years
- ECOG performance status 0-1
- Patients with AJCC v.9 stage I-III disease who undergo chemoradiotherapy
Key exclusion criteria (6 listed)
- Presence of distant metastasis
- Patients with AJCC v.9 cT1N0M0 disease who undergo radiotherapy alone.
- Synchronous or prior invasive malignancy, unless disease-free for at least 2 years.
- Prior radiotherapy to the head and neck region
- Presence of severe major organ dysfunction
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 |
|---|---|---|
| Proton chemoradiotherapyConcurrent chemoradiotherapy will be delivered using intensity modulated proton therapy, with a total dose of 69.96 CGE administered in 33 fractions. | Radiation | Proton chemoradiotherapy |
| Photon chemoradiotherapyConcurrent chemoradiotherapy will be delivered using photon-based volumetric modulated arc therapy, with a total dose of 69.96 Gy administered in 33 fractions. | Radiation | Photon chemoradiotherapy |
Primary outcome
Overall survival
Time frame: 2 years
Overall survival is defined as the time from signing the informed consent to death from any cause.
3 secondary outcomes
Progression free survival
Time frame: 2 years
Time to progression
Time frame: 2 years
Incidence and severity of adverse events
Time frame: 5 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 24 Nov 2025.
- Individual participant dataSharing planned: No. The sharing of individual participant data (IPD) will be conducted only after obtaining approval from the Institutional Review Board (IRB) and in accordance with applicable ethical and data protection regulations.
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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.
Rodney Cheng En Hsieh, MD, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NPC Patients and Nasopharyngeal Cancinoma (NPC), run by Cheng-En Hsieh at 1 site in Taiwan.
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 12 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 Taiwan. 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.
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 Rodney Cheng-En Hsieh, MD, PhD (+886-3-328-1200 ext. 7000, rodney445@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall 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 24 Nov 2025.