NCT06846450 Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
| NCT ID | NCT06846450 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Lin Kong, MD |
| Condition | Nasopharyngeal Cancinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 470 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2031-01-31 |
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 470 participants in total. It began in 2025-04-01 with a primary completion date of 2031-01-31.
⚠ 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
The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).
Eligibility Criteria
Inclusion criteria: * Willingness to sign the written informed consent. * Pathologically confirmed Nasopharyngeal carcinoma. * Patients with any stage of disease except distant metastasis. * Age: ≥ 18 and ≤ 70 years old. * Eastern Cooperative Oncology Group score: 0-1. * Adequate laboratory test results. * Willingness to accept adequate contraception. Exclusion criteria: * Presence of distant metastasis. * Previous radiotherapy to head and neck region. * Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes. * History of malignant tumor within the past 5 years. * Presence of multiple primary tumors. * Presence of diseases that may interfere with the evaluation of study endpoints. * Presence of severe major organ dysfunction. * Mental illness that may affect the understanding of informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06846450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Cancinoma (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 NCT06846450 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 470 participants.
Is NCT06846450 currently recruiting?
Yes, NCT06846450 is actively recruiting participants. Contact the research team at konglinjiang@163.com for enrollment information.
Where is the NCT06846450 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06846450 clinical trial?
NCT06846450 is sponsored by Lin Kong, MD. The trial plans to enroll 470 participants.