Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 NPC

NCT07248670 | Active Not Recruiting Phase 3

• 1 other identifier: CZLL2025-031-001
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Nasopharyngeal Carcinoma; Metronomic Capecitabine; EBV DNA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• DMFS

  3-year

• LRRFS

  3-year

• OS

  3-year

Study Arms (2)

observation

NO INTERVENTION

observation after CCRT

metronomic adjuvant chemotherapy with capecitabine

EXPERIMENTAL

metronomic adjuvant chemotherapy with capecitabine after CCRT.

Drug: metronomic adjuvant chemotherapy with capecitabine

Interventions

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.

metronomic adjuvant chemotherapy with capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years.
• Pathologically confirmed, previously untreated "non-keratinizing carcinoma (WHO types II/III)" of the nasopharynx.
• Diagnosed as stage T1-2N1M0 (Stage IB) according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
• Presence of at least one of the following high-risk lymph node features: more than three metastatic cervical lymph nodes (retropharyngeal lymph nodes are not counted), presence of nodal necrosis, or presence of nodal confluence.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Detectable baseline plasma EBV DNA, with EBV DNA remaining detectable at any time point from the second week after the start of concurrent chemoradiotherapy until the end of radiotherapy.
• Adequate bone marrow function, liver and renal function.

You may not qualify if:

• Intolerance or allergy to capecitabine.
• Conditions that may interfere with the absorption or adherence to oral medication, such as dysphagia, chronic diarrhea, or intestinal obstruction.
• Administration of biologic therapy or immunotherapy during or prior to radiotherapy.
• Pregnancy or lactation (a pregnancy test should be considered for women of childbearing potential, and emphasis must be placed on effective contraception during the treatment period).
• Any concurrent severe or uncontrolled medical condition that would pose an unacceptable risk or compromise protocol compliance, including but not limited to untreated unstable cardiac disease, renal disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \>1.5×ULN), or mood disorders.

Sponsors & Collaborators

• Chongqing University Cancer Hospital: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the hospital

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 4, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CN (1)