Personalized target volume approach for nasopharyngeal cancer radiotherapy
Official title: Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial
Run by Sun Yat-sen University · NCT07661771 · Data updated 2026-11-12
This trial tests whether delineating the primary clinical target volume using a margin-expansion method works as well as the standard guideline-based method in newly diagnosed non-metastatic nasopharyngeal cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 568 (estimated) |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 7 sites (Dongguan, Guangdong and 6 other locations) |
| Status | Recruiting |
| Started | July 24, 2026 |
| Main results expected | July 30, 2029 |
| Study ends | July 30, 2034 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07661771 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with newly diagnosed non-metastatic non-keratinizing nasopharyngeal carcinoma (T1–4N0–3M0), good performance status, and adequate organ function.
✕Probably not a fit
Patients whose tumors require complex contouring beyond margin-based assumptions or who experience relapse despite treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this multicenter, randomized phase 3 study, patients with newly diagnosed non-metastatic nasopharyngeal carcinoma are assigned to receive IMRT using either a margin-expansion–based primary clinical target volume (CTVp) or the consensus guideline–based CTVp. The primary goal is to show non-inferiority of the margin-expansion approach with local relapse-free survival as the primary endpoint. Secondary outcomes include overall and failure-free survival, distant and regional relapse-free survival, treatment-related toxicity, quality of life, and explorations of tumor immune environment and underlying biology. Eligibility includes adults 18–65 with confirmed non-keratinizing NPC, staged T1–4N0–3M0, good performance status, and adequate organ function. Treatment will follow standard guidelines and be stratified by tumor stage across participating centers in China.
Why it matters
Potential benefit: If successful, patients could receive equally effective radiotherapy with a potentially simpler or more consistent target delineation method.
How similar studies have gone: Prior studies in radiotherapy target delineation have shown that margin-based approaches can be feasible; this trial tests non-inferiority against existing consensus practices.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Age: 18 Years to 65 Years.
2. Eastern Cooperative Oncology Group performance status ≤1.
3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma (non-keratinizing subtype).
4. Tumor staged as T1-4N0-3M0 (AJCC 9th).
5. 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.
6. Women of childbearing potential and male subjects with female partners of childbearing potential must agree to use reliable contraceptive measures from screening to 1 year after treatment.
7. For subjects requiring chemotherapy, the following are additionally required:
1. normal bone marrow function (white blood cell count \> 4 × 10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100 × 10\^9/L);
2. normal liver and kidney function (total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2.5 × upper limit of normal, alkaline phosphatase ≤ 2.5 × upper limit of normal, creatinine clearance rate ≥ 60 mL/min).
Exclusion Criteria:
1. Active tuberculosis: active tuberculosis within the past 1 year should be excluded regardless of treatment; a history of active tuberculosis \> 1 year ago is exclusionary unless prior adequate anti-tuberculosis treatment is documented.
2. Active infection requiring systemic treatment.
3. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer.
4. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma.
5. Prior or concurrent treatment for local or regional disease other than that specified in the research plan.
6. Pregnant or lactating women (a pregnancy test is required for women of childbearing potential).
7. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast.
8. History of psychiatric disorders, alcoholism or drug abuse, and other situations assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.
9. For participants requiring chemotherapy, the following must also be excluded:
1. anti-human immunodeficiency virus positive or diagnosed with acquired immune deficiency syndrome;
2. uncontrolled heart disease (heart failure \[NYHA Class ≥ 2\], unstable angina, myocardial infarction in past 1 year, supraventricular or ventricular arrhythmia requiring treatment or intervention).
10. For participants requiring immunotherapy, the following must also be excluded:
1. hepatitis B virus surface antigen positive and Hepatitis B virus DNA \> 1000 copies/mL;
2. anti-hepatitis C virus positive;
3. active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary disease, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators, exceptions are type I diabetes mellitus, hypothyroidism not requiring hormone replacement therapy, skin disorders not requiring systemic treatment \[such as vitiligo, psoriasis or alopecia\]);
4. previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy;
5. chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day, subjects who use inhaled or topical corticosteroids are eligible) or any other form of immunosuppressive therapy;
6. allergy to macromolecular protein preparations, or any component of PD-1 monoclonal antibody;
7. receiving live vaccine within 30 days prior to the first dose of PD-1 monoclonal antibody.
Where it's running
-
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China Recruiting -
Dongguan People's Hospital
Dongguan, Guangdong, China Not yet recruiting -
First People's Hospital of Foshan
Foshan, Guangdong, China Not yet recruiting -
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China Not yet recruiting -
Zhongshan City People's Hospital
Zhongshan, Guangdong, China Not yet recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Not yet recruiting
Show 1 more location
-
Xiangya Hospital Central South University
Changsha, Hunan, China Not yet recruiting
Study contacts
- Principal investigator: Jun Ma, Prof. — Sun Yat-sen University
- Study coordinator: Jun Ma, Prof.
- Email: majun2@mail.sysu.edu.cn
- Phone: +86-20-87343469
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.