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A randomized, open, controlled, phase III study of capecitabine chemotherapy in locally advanced or post-radiotherapy EBV-DNA high-titer nasopharyngeal carcinoma

A randomized, open, controlled, phase III study of capecitabine chemotherapy in locally advanced or post-radiotherapy EBV-DNA high-titer nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049383
Enrollment
Unknown
Registered
2021-08-01
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal carcinoma

Interventions

Experimental group:Capecitabine adjuvant chemotherapy
Control group:None

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients with locally advanced nasopharyngeal carcinoma who received radiotherapy or 4-8 weeks after radiotherapy were positive for EBV-DNA; 2.Aged 18 to 70 years; 3.KPS>=70 points; 4.During radiotherapy, platinum weekly chemotherapy was synchronized, and the radiotherapy dose was >=66Gy (whether or not induced chemotherapy was received); 6.Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Being treated with other anti-tumor drugs; 2.Have a prior or concurrent diagnosis of other malignant tumors (except those that have been cured and have survived for more than 5 years without cancer); 3.Have received adjuvant chemotherapy in the past; 4.Pregnancy or breastfeeding; 5.Kidney disease, severe cardiovascular and cerebrovascular disease, mental illness, uncontrolled diabetes and other diseases; 6.Liver and kidney function were impaired and bone marrow function was inhibited.

Design outcomes

Primary

MeasureTime frame
Progression-free survival ;

Secondary

MeasureTime frame
Overall survival;Acute phase toxicity;Long term toxicity;Distant metastasis rate;

Countries

China

Contacts

Public ContactGao Jing

Anhui Provincial Cancer Hospital

gjfl2011@126.cm+86 15395005376

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026