Combining radiotherapy with endostatin and capecitabine for nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial investigates the effectiveness of radiotherapy combined with recombinant human endostatin and capecitabine in patients with nasopharyngeal carcinoma (NPC) who are resistant to induction chemotherapy. The study involves 41 patients with locally advanced NPC, focusing on their recurrence-free survival as the primary endpoint. Secondary objectives include overall survival, distant metastasis-free survival, local-regional free survival, and the assessment of adverse events and quality of life. The trial is designed to provide insights into the safety and efficacy of this combined treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition).

No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) \> 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent.

unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting
• the First Hospital of Jiaxing
  Jiaxing, Zhejiang, China Recruiting
• Jinhua Central Hospital
  Jinhua, Zhejiang, China Recruiting
• The Central Hospital of Lishui City
  Lishui, Zhejiang, China Recruiting
• Ningbo First Hospital
  Ningbo, Zhejiang, China Recruiting
• Ningbo Medical Center Lihuili Eastern Hospital
  Ningbo, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Jin, MD
• Email: jinting@zjcc.org.cn
• Phone: +86-571-88128202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.