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Capecitabine monotherapy for locally persistent nasopharyngeal carcinoma after radical chemoradiotherapy: A prospective, single-arm, phase II clinical trial.

Capecitabine monotherapy for locally persistent nasopharyngeal carcinoma after radical chemoradiotherapy: A prospective, single-arm, phase II clinical trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025216
Enrollment
Unknown
Registered
2019-08-16
Start date
2019-09-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

nasopharyngeal Carcinoma

Interventions

Case series:capecitabine monotherapy

Sponsors

Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed WHO type II or III nasopharyngeal carcinoma; 2. Initial treatment adopted radical radiotherapy with or without chemotherapy; 3. Pathologically confirmed nasopharyngeal tumor and / or cervical lymph node residual at the time of 3-6 months after the initial treatment; and / or nasopharyngeal + neck MRI considered tumor residual at the time of 3 months after the initial treatment and two or more imaging expert diagnosis of nasopharyngeal tumor and / or cervical lymph node residual after a month waiting; 4. Not suitable for local treatment, mainly referring to anti-tumor treatment, including surgery and radiotherapy; 5. Male or female, 18–70 years old; 6. Karnofsky performance scoring >=70; 7. No severe heart, lung, liver, kidney and other important organ dysfunction; 8. normal renal and hepatic function: ALT and AST = 60 mL/min; Adequate bone marrow function: absolute white blood cell count >4.0x10^9/L, neutrophil >2.0x10^9/L, hemoglobin >90 g/L, platelets >100x10^9/L); 9. Written informed consent with exact date obtained from the individual patients before certain proposed step.

Exclusion criteria

Exclusion criteria: 1. Detection of distant metastasis before treatment; 2. Pregnancy or breast feeding; 3. Informed consent refusal; 4. Patients unable to be followed up regularly; 5. Accompanied by serious uncontrollable infection or medical diseases; 6. Inadequate organ function and cannot tolerate chemotherapy; 7. Conditions that may adversely affect pharmacokinetics: such as psychiatric disorders, central nervous system disorders, chronic diarrhea, ascites and hydrothorax; 8. Long-term treatment with immune-suppressor after organ transplantation; 9. Other malignancy before inclusion.

Design outcomes

Primary

MeasureTime frame
3-year progression-free survival;

Secondary

MeasureTime frame
3-year overall survival;Drug safety;Drug safety;objective response rate;living quality;

Countries

China

Contacts

Public ContactLv Xing

Department of Nasopharyngeal Carcinoma, Cancer Center, Sun Yat-sen University

lvxing@sysucc.org.cn+86 15920182400

Outcome results

None listed

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