Comparing reduced dose and standard dose radiotherapy for early stage nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of reduced dose radiotherapy compared to standard dose radiotherapy in patients with early stage nasopharyngeal carcinoma. Patients will receive intensity-modulated radiotherapy and will be randomized into two groups: one receiving reduced dose treatment and the other receiving standard dose treatment. The primary goal is to determine if the reduced dose is non-inferior in terms of 3-year locoregional relapse-free survival rates. The study includes patients with stage I nasopharyngeal carcinoma who are sensitive to radiotherapy and have achieved complete response after initial treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-70, regardless of sex.
2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer\[AJCC\] edition).
3. Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
4. ECOG (Eastern Cooperative Oncology Group) score: 0-1.
5. Women in their reproductive years should ensure that they use contraception during the study period.
6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.5×ULN.
8. Renal function: serum creatinine \<1.5×ULN or creatinine clearance rate≥60mL/min.
9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion Criteria:

1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
2. Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
3. Receiving radiotherapy or chemotherapy or targeted therapy previously.
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
6. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
7. Severe, uncontrolled medical conditions and infections.
8. At the same time using other test drugs or in other clinical trials.
9. Refusal or inability to sign informed consent to participate in the trial.
10. Other treatment contraindications.
11. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

Where it's running

• Sun Yat-sen University Cancer Centre
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hai-Qiang Mai, Dr.
• Email: maihq@sysucc.org.cn
• Phone: +8602087343380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.