Clinical trial · Interventional
A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA
Phase III Randomized Trial of Immediate Adjuvant Chemotherapy or Delayed Salvage Chemotherapy in Nasopharyngeal Carcinoma Patients With Post-radiation Detectable Plasma EBV DNA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruiting progress behind expectation
Summary
Brief summary (as posted)
Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high incidence of lymphatic and hematological dissemination. Because of the inherent anatomic constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary treatment for NPC patients. NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been used to treat NPC patients with advanced-stage diseases during recent 20 years. However, treatment outcome for locoregionally advanced NPC is still unsatisfactory.
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 | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant Chemotherapy
- description
- MEP followed by oral Tegafur-uracil
- interventionNames
- Drug: MEP
- type
- NO_INTERVENTION
- label
- control arm
- description
- closely followed with frequency similar to the experiemental arm
Primary outcomes (1)
- measure
- Time to progression
- timeFrame
- 5 years
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1.Histological proven NPC. 2.2010 AJCC stage II-IVB. 3.Age ≧ 20 years old. 4.Performance status of ECOG ≦ 2. 5.Finished RT ≧ 66 Gy (± induction and/or concurrent chemotherapy). 6.pEBV DNA \> 0 copy/ml at 1±1 week post-RT. 7.Re-staging work-ups at 10±2 weeks post-RT showing no active lesions. 8.Adequate liver, renal, and bone marrow function 4 weeks before randomization. 9.Signed informed consent. Exclusion Criteria: 1. Pathologically-proven the presence of locoregional disease and/or distant metastasis. 2. Unequivocally-shown active NPC (locoregional/distant) by imaging studies. 3. Inadequate RT. 4. Received any post-RT adjuvant chemotherapy. 5. pEBV DNA = 0 copy/ml at 1±1 week post-RT. 6. Previous delivery of cisplatin dose \> 600 mg/m2. 7. Previous delivery of epirubicin \> 360 mg/m2. 8. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of breast. 9. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders. 10. Female patients who are pregnant or lactating.
References
Publications (0)
Data not yet available