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This Phase III multicenter trial investigates treatment intensification for high-risk, stage T1-2N1M0 nasopharyngeal carcinoma. Patients with high-risk features (>3 metastatic lymph nodes, necrosis, or confluence) receive concurrent chemoradiotherapy. Those with detectable EBV DNA during radiotherapy are randomized 1:1 to adjuvant capecitabine or observation alone to assess efficacy and safety
This is a multicenter, randomized, phase III trial enrolling patients with AJCC/UICC 9th edition stage T1-2N1M0 nasopharyngeal carcinoma who have at least one of the following high-risk features: more than 3 metastatic cervical lymph nodes, presence of nodal necrosis, or presence of nodal confluence. All patients receive concurrent chemoradiotherapy (CCRT) with a weekly cisplatin regimen. Plasma EBV DNA is monitored weekly during CCRT. High-risk patients with detectable EBV DNA at any time from the second week of CCRT until the end of radiotherapy are randomized in a 1:1 ratio to receive either metronomic adjuvant chemotherapy with capecitabine or follow-up observation alone, to evaluate the efficacy and safety of treatment intensification
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| observation | No Intervention | observation after CCRT | |
| metronomic adjuvant chemotherapy with capecitabine | Experimental | metronomic adjuvant chemotherapy with capecitabine after CCRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metronomic adjuvant chemotherapy with capecitabine | Drug | The concurrent chemoradiotherapy (CCRT) regimen consisted of IMRT delivering 69.96 Gy in 33 fractions, combined with cisplatin administered at 35-40 mg/m² weekly for 6 cycles to achieve a cumulative dose of ≥200 mg/m². During CCRT, plasma EBV DNA titer was monitored weekly. If EBV DNA remained undetectable from the second week after CCRT initiation until the end of radiotherapy, patients underwent observation after radiotherapy. If EBV DNA was detectable at any time point from the second week of CCRT until the end of radiotherapy, patients were randomized in a 1:1 ratio to observation or metronomic adjuvant chemotherapy with capecitabine (650 mg/m² twice daily, Q3W) for 8 cycles (6 months) after radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| FFS | FFS is defined as the time from randomization to the first occurrence of local regional recurrence, distant metastasis, or death from any cause | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| DMFS | 3-year | |
| LRRFS | 3-year | |
| OS | 3-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
Due to ethical considerations, contact us via email if needed.
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |