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Compares treatment options for Nasopharyngeal Carcinoma
Official title Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07000643
What this study is testing
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed written informed consent prior to the implementation of any trial-related procedures; No gender restriction, age ≥18 years and ≤75 years...
- Adequate organ function, people must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥1.5x10⁹/L. Platelets ≥75×10⁹/L. Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L; Aspartate aminotransferase (AST) and...
You likely can't join if
- Presence of distant metastatic lesions (M1). Primary squamous cell carcinoma of the head and neck not originating in the nasopharynx.
- Diagnosis of types other than nasopharyngeal keratinizing carcinoma and non-keratinizing carcinoma; (Note: The inclusion criteria state WHO types...
- Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal at the respective study...
- HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose; people should receive anti-HBV therapy throughout the study drug treatment period...
- For people who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring...
- Active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Pregnant women;
See the full eligibility criteria
- Signed written informed consent prior to the implementation of any trial-related procedures; No gender restriction, age ≥18 years and ≤75 years; Histologically confirmed, according to the latest WHO classification...
- Adequate organ function, people must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥1.5x10⁹/L. Platelets ≥75×10⁹/L. Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN (Upper Limit of Normal) Serum...
- Presence of distant metastatic lesions (M1). Primary squamous cell carcinoma of the head and neck not originating in the nasopharynx.
- Diagnosis of types other than nasopharyngeal keratinizing carcinoma and non-keratinizing carcinoma; (Note: The inclusion criteria state WHO types: keratinizing, non-keratinizing differentiated, and undifferentiated...
- Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal at the respective study center's laboratory); Note: Hepatitis B people meeting the following...
- HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose; people should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation.
- For people who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.
- Active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Pregnant women;
- Presence of any severe or uncontrolled systemic diseases, for example:
- Significant and symptomatically severe, difficult-to-control abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.