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New treatment option for Nasopharyngeal Carcinoma (NPC)
Official title Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC
ClinicalTrials.gov ID: NCT07303023
What this study is testing
- What it's testing
- Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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 70. Healthy volunteers may be eligible.
You may be able to join if
- Age 18-70 years.
- Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma.
- Staged as T1-4N0-3 M0, Stage I-III according to the UICC/AJCC 9th edition staging system.
- Absence of distant metastasis confirmed by systemic FDG PET/CT (or whole-body bone scan plus chest CT and abdominal ultrasound).
- Ability to undergo MRI examination.
You likely can't join if
- Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma.
- Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes.
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation.
- Unwillingness to provide informed consent.
- Prior radiotherapy to the head and neck region.
- Comorbidities or other factors that may contraindicate photon or carbon-ion therapy.
See the full eligibility criteria
- Age 18-70 years.
- Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma.
- Staged as T1-4N0-3 M0, Stage I-III according to the UICC/AJCC 9th edition staging system.
- Absence of distant metastasis confirmed by systemic FDG PET/CT (or whole-body bone scan plus chest CT and abdominal ultrasound).
- Ability to undergo MRI examination.
- Adequate major organ function meeting radiotherapy requirements:
- Hematopoietic function: Hemoglobin ≥9 g/L, Platelets ≥100×10⁹/L, WBC ≥3.5×10⁹/L, Neutrophils ≥2.0×10⁹/L.
- Liver function: ALT and AST \< 2.5 × ULN, Bilirubin \< 1.5 × ULN.
- Renal function: Creatinine clearance ≥50 mL/min or serum creatinine within normal range.
- Patients with clinical symptoms will be evaluated based on specific manifestations.
- ECOG performance status 0-1; absence of severe comorbidities (e.g., severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease) that may preclude radiotherapy...
- Life expectancy ≥12 months.
- Patients must be informed of the study details and provide written informed consent.
- Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma.
- Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes.
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation.
- Unwillingness to provide informed consent.
- Prior radiotherapy to the head and neck region.
- Comorbidities or other factors that may contraindicate photon or carbon-ion therapy.
- Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons.
- Known allergy to chemotherapeutic agents (e.g., cisplatin, docetaxel, gemcitabine) or contrast media used in the study's imaging examinations.
- Contraindication to contrast-enhanced MRI.
- Major organ dysfunction, or severe uncontrolled concurrent infection or medical illness (e.g., decompensated cardiac, pulmonary, renal, or hepatic failure).
- History of immunodeficiency (positive HIV test), other acquired/congenital immunodeficiency disorders, or history of organ/allogeneic bone marrow transplantation.
- History of other malignancies prior to enrollment (except for basal cell carcinoma of the skin).
- History of substance or alcohol abuse.
- Any other condition deemed by the investigator to potentially lead to study discontinuation, including co-morbidities (including psychiatric) requiring concomitant treatment, severely abnormal laboratory values, or...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Hangzhou, Zhejiang, China
- Chengdu, China
- Chongqing, China
- Shanghai, 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 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China; Chengdu, China; Chongqing, China; Shanghai, 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.