Clinical trial · Interventional
Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma
Individualized Primary Clinical Target Volume Based on Margin Expansion for Nasopharyngeal Carcinoma: A Non-Inferiority, Multicenter, Randomized Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a non-inferiority, multicenter, randomized phase 3 trial aimed to evaluate whether primary clinical target volume (CTVp) delineation based on margin expansion provides comparable outcomes compared with the consensus CTVp approach based on margin expansion and the stepwise extension pattern in newly diagnosed non-metastatic nasopharyngeal carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-metastatic Nasopharyngeal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Therapy Based on Tumor Stage | Procedure | — | UNRESOLVED |
| IMRT with Consensus Primary Clinical Target Volume | Radiation | — | UNRESOLVED |
| IMRT with Primary Clinical Target Volume Based on Margin Expansion | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Primary Clinical Target Volume Based on Margin Expansion
- description
- During radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion.
- interventionNames
- Procedure: Comprehensive Therapy Based on Tumor Stage
- Radiation: IMRT with Primary Clinical Target Volume Based on Margin Expansion
- type
- ACTIVE_COMPARATOR
- label
- Consensus Primary Clinical Target Volume Based on Margin Expansion and Stepwise Extension Pattern
- description
- During radiotherapy, the clinical target volume for the primary tumor will be delineated based on margin expansion and local stepwise extension patterns according to the CSTRO, CACA, CSCO, HNCIG, ESTRO, and ASTRO guidelines and contouring atlas.
- interventionNames
- Procedure: Comprehensive Therapy Based on Tumor Stage
- Radiation: IMRT with Consensus Primary Clinical Target Volume
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.References
Publications (19)
- BACKGROUNDWong KCW, Hui EP, Lo KW, Lam WKJ, Johnson D, Li L, Tao Q, Chan KCA, To KF, King AD, Ma BBY, Chan ATC. Nasopharyngeal carcinoma: an evolving paradigm. Nat Rev Clin Oncol. 2021 Nov;18(11):679-695. doi: 10.1038/s41571-021-00524-x. Epub 2021 Jun 30. PMID 34194007
- BACKGROUNDChen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6. PMID 31178151
- BACKGROUNDLiang YL, Liu X, Shen LF, Hu GY, Zou GR, Zhang N, Chen CB, Chen XZ, Zhu XD, Yuan YW, Yang KY, Jin F, Hu WH, Xie FY, Huang Y, Han F, Tang LL, Mao YP, Lu LX, Sun R, He YX, Zhou YY, Long GX, Tang J, Chen LS, Zong JF, Jin T, Li L, Lin J, Huang J, Gong XY, Zhou GQ, Chen L, Li WF, Chen YP, Xu C, Lin L, Huang SH, Huang SW, Wang YQ, Huang CL, Feng HX, Hou M, Chen CH, Zheng SF, Li YQ, Hong SB, Jie YS, Li H, Yun JP, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Li JB, Lin AH, Liu N, Zhang Y, Guo R, Ma J, Sun Y. Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1589-1598. doi: 10.1001/jama.2025.1132. PMID 40079940
- BACKGROUNDLiu X, Zhang Y, Yang KY, Zhang N, Jin F, Zou GR, Zhu XD, Xie FY, Liang XY, Li WF, He ZY, Chen NY, Hu WH, Wu HJ, Shi M, Zhou GQ, Mao YP, Guo R, Sun R, Huang J, Liang SQ, Wu WL, Su Z, Li L, Ai P, He YX, Zang J, Chen L, Lin L, Huang SH, Xu C, Lv JW, Li YQ, Hong SB, Jie YS, Li H, Huang SW, Liang YL, Wang YQ, Peng YL, Zhu JH, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Lin AH, Li JB, Liu N, Tang LL, Chen YP, Sun Y, Ma J. Induction-concurrent chemoradiotherapy with or without sintilimab in patients with locoregionally advanced nasopharyngeal carcinoma in China (CONTINUUM): a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2720-2731. doi: 10.1016/S0140-6736(24)00594-4. Epub 2024 May 30. PMID 38824941
- BACKGROUNDLee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4.