Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 NPC (NCT07248670) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 NPC
China252 participantsStarted 2025-10-04
Plain-language summary
This Phase III multicenter trial investigates treatment intensification for high-risk, stage T1-2N1M0 nasopharyngeal carcinoma. Patients with high-risk features (\>3 metastatic lymph nodes, necrosis, or confluence) receive concurrent chemoradiotherapy. Those with detectable EBV DNA during radiotherapy are randomized 1:1 to adjuvant capecitabine or observation alone to assess efficacy and safety
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 18 to 70 years.
. Pathologically confirmed, previously untreated "non-keratinizing carcinoma (WHO types II/III)" of the nasopharynx.
. Diagnosed as stage T1-2N1M0 (Stage IB) according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
. Presence of at least one of the following high-risk lymph node features: more than three metastatic cervical lymph nodes (retropharyngeal lymph nodes are not counted), presence of nodal necrosis, or presence of nodal confluence.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Detectable baseline plasma EBV DNA, with EBV DNA remaining detectable at any time point from the second week after the start of concurrent chemoradiotherapy until the end of radiotherapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate bone marrow function, liver and renal function.
Exclusion criteria
. Intolerance or allergy to capecitabine.
. Conditions that may interfere with the absorption or adherence to oral medication, such as dysphagia, chronic diarrhea, or intestinal obstruction.
. Administration of biologic therapy or immunotherapy during or prior to radiotherapy.
. Pregnancy or lactation (a pregnancy test should be considered for women of childbearing potential, and emphasis must be placed on effective contraception during the treatment period).
. Any concurrent severe or uncontrolled medical condition that would pose an unacceptable risk or compromise protocol compliance, including but not limited to untreated unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \>1.5×ULN), or mood disorders.