Clinical trial · Interventional
Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma
Induction Chemotherapy Response-Guided Reduced-Dose Radiotherapy for Nasopharyngeal Carcinoma: A Prospective Single-center Randomized Phase II Study
- 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 evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).
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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma (NPC) | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| concurrent chemoradiotherapy | Other | — | UNRESOLVED |
| reduced dose group | Radiation | — | UNRESOLVED |
| Standard Dose Group | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- reduced dose group
- interventionNames
- Radiation: reduced dose group
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- standard dose group
- interventionNames
- Radiation: Standard Dose Group
- type
- OTHER
- label
- Corhort 2
- interventionNames
- Other: concurrent chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 - 65 years old. * Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing cancer. * AJCC/UICC 9th edition stage IB-II untreated non-metastatic nasopharyngeal carcinoma (T3 requires no extensive cranial base invasion and the invasion volume should be \< 22 mL; N1-2 requires baseline lymph nodes \< 4 cm). * Before treatment, plasma EBV-DNA needs to be tested and dynamic monitoring of EBV-DNA can be completed. * ECOG performance status 0 - 1 points. * Main organ functions meet the following requirements: neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 mL/min. * Sign a written informed consent form and be willing to complete the treatment, follow-up and quality of life assessment according to the protocol. Exclusion Criteria: * Metastasis to T4, N3 or distant sites; AJCC/UICC 9th edition stage III-IV. * Had received chemotherapy, targeted therapy, or immunotherapy before the diagnosis of nasopharyngeal carcinoma, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies). * Pregnant or lactating; non-pregnant and non-lactating subjects who do not agree to take effective contraceptive measures. * Had severe and uncontrollable heart, lung, liver, kidney, neurological or mental diseases, and the investigator judged that they were not suitable for radical treatment or affected compliance. * Had a history of other malignant tumors within the past 5 years, except for the following situations: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc. * Could not complete the imaging examinations, EBV-DNA tests, follow-up or quality of life assessment as required by the protocol.
References
Publications (0)
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