NCT07340515 Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
| NCT ID | NCT07340515 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Man Hu |
| Condition | Nasopharyngeal Carcinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-12-15 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma. All patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase. The primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.
Eligibility Criteria
Inclusion Criteria: * Age 18 to 70 years * Histologically confirmed nasopharyngeal carcinoma (WHO type II or III) * High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system * No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate organ function as defined in the study protocol * Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol * Ability to understand and willingness to sign written informed consent Exclusion Criteria: * Evidence of distant metastasis (M1 disease) * Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma * Active autoimmune disease requiring systemic therapy * Uncontrolled infection or severe comorbidities that may affect treatment tolerance * Pregnancy or breastfeeding * Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation
Frequently Asked Questions
Who can join the NCT07340515 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Carcinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07340515 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07340515 currently recruiting?
Yes, NCT07340515 is actively recruiting participants. Visit ClinicalTrials.gov or contact Man Hu to inquire about joining.
Where is the NCT07340515 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07340515 clinical trial?
NCT07340515 is sponsored by Man Hu. The trial plans to enroll 300 participants.