Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

NCT06846450 | Recruiting Phase 3 DMC

• 1 other identifier: SPHIC-TR-HNCNS-2024-70
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Proton; Photon; Carbon ion; Phase 3 Trial; Locally Advanced NPC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival (PFS) defined as the time interval from randomization to death or disease progression whichever comes first.

  3 years

Secondary Outcomes (10)

• Overall survival

  3 years

• Locoregional progression-free survival

  3 years

• Distant metastasis-free survival

  3 years

• Prevalence of grade ≥2 acute toxicities

  3 years

• Prevalence of grade ≥3 acute toxicities

  3 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Radiation: Intensity-modulated proton radiation therapy; Radiation: Intensity-modulated carbon ion radiation therapy; Drug: Concurrent chemotherapy; Drug: Induction chemotherapy

Arm 2

ACTIVE COMPARATOR

Radiation: Intensity-modulated photon radiation therapy; Radiation: Intensity-modulated carbon ion radiation therapy; Drug: Concurrent chemotherapy; Drug: Induction chemotherapy

Interventions

Intensity-modulated proton radiation therapy RADIATION

Intensity-modulated proton therapy, will be delivered to the high risk area with a dose of 56 GyRBE in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 GyRBE in 28 fractions.

Also known as: IMPT

Arm 1

Intensity-modulated photon radiation therapy RADIATION

Intensity-modulated photon therapy, will be delivered to the high risk area with a dose of 56 Gy in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 Gy in 28 fractions.

Also known as: IMRT

Arm 2

Intensity-modulated carbon ion radiation therapy RADIATION

Intensity-modulated carbon ion radiation therapy will be delivered as a boost with a dose of 17.5 GyRBE in 5 fractions to gross tumor.

Also known as: IMCT

Arm 1; Arm 2

Concurrent chemotherapy DRUG

Concurrent chemotherapy will be administered on a weekly basis.

Arm 1; Arm 2

Induction chemotherapy DRUG

Cisplatin-based induction chemotherapy will be administered every three weekly.

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lin Kong, MD: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

Related Publications (21)

• Hu J, Huang Q, Gao J, Hu W, Yang J, Guan X, Qiu X, Zhang W, Kong L, Lu JJ. Mixed Photon and Carbon-Ion Beam Radiotherapy in the Management of Non-Metastatic Nasopharyngeal Carcinoma. Front Oncol. 2021 Jul 23;11:653050. doi: 10.3389/fonc.2021.653050. eCollection 2021.

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• Li X, Kitpanit S, Lee A, Mah D, Sine K, Sherman EJ, Dunn LA, Michel LS, Fetten J, Zakeri K, Yu Y, Chen L, Kang JJ, Gelblum DY, McBride SM, Tsai CJ, Riaz N, Lee NY. Toxicity Profiles and Survival Outcomes Among Patients With Nonmetastatic Nasopharyngeal Carcinoma Treated With Intensity-Modulated Proton Therapy vs Intensity-Modulated Radiation Therapy. JAMA Netw Open. 2021 Jun 1;4(6):e2113205. doi: 10.1001/jamanetworkopen.2021.13205.

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• Zhou X, Ou X, Xu T, Wang X, Shen C, Ding J, Hu C. Effect of dosimetric factors on occurrence and volume of temporal lobe necrosis following intensity modulated radiation therapy for nasopharyngeal carcinoma: a case-control study. Int J Radiat Oncol Biol Phys. 2014 Oct 1;90(2):261-9. doi: 10.1016/j.ijrobp.2014.05.036. Epub 2014 Jul 24.

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MeSH Terms

Interventions

Induction Chemotherapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Central Study Contacts

Lin Kong

CONTACT

86-38296666; konglinjiang@163.com

Jiyi Hu

CONTACT

86-38296666; jiyi.hu@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: This study adopts a web-based central randomization system. The randomization method uses minimization, with two balancing factors: Stage (AJCC Staging System, 9th edition): Stage I vs. Stages II/III; Response to induction chemotherapy: No induction chemotherapy vs. sensitive (CR + PR) vs. resistant (SD + PD). Eligible patients will be randomized in a 1:1 ratio into either the experimental group or the control group. This is an open-label study, meaning both patients and investigators are aware of the treatment allocation.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 26, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: December 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Anonymized IPD will be shared within 3 years after publication of the primary, secondary and safety results of the study.
• Access Criteria: Data may be shared with qualified researchers who are interested in examining the efficacy and toxicity of nasopharyngeal carcinoma patients treated with particle beam radiotherapy. Pooled analysis comparing IMRT and particle beam radiotherapy will be of particular interest. Detailed study protocol should be emailed along with the request of the data. We may carefully review the study protocol, and data will only be shared with well-designed studies.

Locations

CN (1)