Could radiation alone be enough for some nasopharyngeal cancers?
NCT ID NCT02633202
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested whether giving only radiation therapy works as well as radiation plus chemotherapy for people with intermediate-risk nasopharyngeal cancer. The study enrolled 338 participants and used modern intensity-modulated radiation therapy (IMRT). The goal was to see if skipping chemotherapy could reduce side effects without harming treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cisplatin chemotherapy plus intensity-modulated radiation therapy (IMRT)
- What this could lead to
- If successful, this could show that radiation alone is enough for intermediate-risk nasopharyngeal cancer, sparing patients from chemotherapy side effects.
- What could go wrong
- This is a completed phase 3 trial, but results may not apply to all patients or settings. The chemotherapy regimen used is intensive and may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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338 people
The number who actually took part.
- Started
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Nov 2015
- Finished
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Oct 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type. * Tumor staged as T1-2N1/T2-3N0(according to the 7th AJCC edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 120g/L for male, ≥ 120g/L for female , and platelet count ≥ 100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN. * Adequate renal function: creatinine clearance ≥ 60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Neck lymph node with extracapsular spread. Maximal axial diameter of neck lymph node ≥30mm, positive neck lymph node at level IV and/or Vb. * Pretreatment plasma EBV DNA level ≥4000 copy/ml. * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age \> 65 or \< 18. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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