Clinical trial · Interventional
Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients
Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal
NCT03839602CI-TRIAL-00037077completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early-stage Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | PROBABILISTIC | 0.70 |
| Intensity Modulated Radiation Therapy | — | UNRESOLVED | — |
| Target Volume Delineation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Reducing CTV | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- reducing CTV
- description
- The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively.
- interventionNames
- Radiation: Reducing CTV
Primary outcomes (1)
- measure
- LRRFS
- timeFrame
- 5 year
- description
- locoregional recurrence free survival
Secondary outcomes (6)
- measure
- Locoregional failure patterns
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. histologically confirmed NPC (WHO II-III) 2. stage I-IIb according to the 6th AJCC/UICC 3. no previous treatment for NPC 4. between 18 and 70 years old 5. KPS ≥ 80 scores 6. adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥ 1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and creatinine clearance rate ≥ 30 mL/min) Exclusion Criteria: 1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT 2. disease progression during IMRT 3. presence of distant metastasis 4. pregnancy or lactation 5. previous malignancy or other concomitant malignant disease
References
Publications (1)
- DERIVEDMiao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6. PMID 32272183