Health TrialsbyHealthPanel

Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMan Hu

About this trial

This study is a prospective, open-label, multicenter, cohort, phase III non-inferiority clinical trial comparing proton therapy with photon radiotherapy for nasopharyngeal carcinoma. It intends to enroll histologically confirmed newly diagnosed nasopharyngeal carcinoma patients without distant metastasis (M0). Through a prospective 1:1 matched cohort study design, patients will be divided into the intensity-modulated proton therapy (IMPT) group and the intensity-modulated radiation therapy (IMRT) group. Systemic treatment regimens are formulated according to clinical guidelines.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensity-Modulated Proton Therapy (IMPT)

    Radiation

    This is the experimental arm intervention. Patients receive Intensity-Modulated Proton Therapy (IMPT) for primary nasopharyngeal carcinoma. The subjects are patients with histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma. Radiotherapy target volumes and doses: GTV (gross tumor volume of primary tumor and metastatic lymph nodes); CTV70Gy (GTVp + 0-5mm margin, GTVn + 0-3mm margin, reducible near organs at risk) at a dose of 69.6-70Gy; CTV50-54Gy (GTVp + 8-10mm margin + entire nasopharyngeal mucosa + adjacent high/intermediate risk structures and intermediate-risk subclinical lymph node regions) at a dose of 50-54Gy, delivered at 2Gy/(RBE) per fraction. The protocol notes that proton therapy does not use a PTV (Planning Target Volume). The systemic therapy plan is formulated according to clinical guidelines.

  • Intensity-Modulated Radiotherapy (IMRT)

    Radiation

    This is the control arm intervention. Patients receive Intensity-Modulated Radiotherapy (IMRT) for primary nasopharyngeal carcinoma; IMRT is one of the current standard and widely used treatment techniques. The subjects are patients with histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma. Radiotherapy target volumes and doses: GTV (gross tumor volume of primary tumor and metastatic lymph nodes); CTV70Gy (GTVp + 0-5mm margin, GTVn + 0-3mm margin); PTV70 (CTV70 + 3-5mm margin, reducible near organs at risk) at a dose of 70Gy; CTV50-54Gy (GTVp + 8-10mm margin + entire nasopharyngeal mucosa + adjacent high/intermediate risk structures and intermediate-risk subclinical lymph node regions); PTV50-54 (CTV50-54 + 3-5mm margin, reducible near organs at risk) at a dose of 50-54Gy, delivered at 2Gy/(RBE) per fraction. The systemic therapy plan is formulated according to clinical guidelines.

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: IMPT GroupExperimental treatment 1 intervention
Group B: IMRT GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

2-year Locoregional Recurrence-Free Survival (LRFS)

Defined as the time from group allocation to local-regional recurrence, including recurrence at the primary site and lymph node regions, or death from any cause.

Time frame
2 years

Secondary outcomes

1

2-year Overall Survival (OS)

Time from group allocation to death from any cause

Time frame
2 years
2

2-year Progression-Free Survival (PFS)

Defined as the time from enrollment to documented disease progression or recurrence, or death from any cause.

Time frame
2 years
3

2-year Distant Metastasis-Free Survival (DMFS)

Time from group allocation to the occurrence of distant metastasis or death from any cause

Time frame
2 years
4

Radiation-related adverse reactions

The severity of acute and late radiation-related adverse reactions (e.g., mucosal reactions, skin reactions, gastrointestinal reactions, myelosuppression, xerostomia, hearing loss, temporal lobe injury, etc.) will be graded and assessed according to NCI CTCAE Version 5.0

Time frame
During the study process and follow-up period (acute adverse reactions assessed mainly during treatment and shortly thereafter; late adverse reactions assessed during long-term follow-up according to the follow-up schedule: every 3 months within 2 years,

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Man Hu

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Source ClinicalTrials.gov
Apply now