Gemcitabine and Cisplatin Treatment for Advanced Nasopharyngeal Cancer
A Multicenter and Prospective Clinical Trial of Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
This study is testing a combination of two chemotherapy drugs, gemcitabine and cisplatin, followed by radiation therapy to see if it helps people with advanced nasopharyngeal cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Fifth Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT04522050 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a treatment regimen combining gemcitabine and cisplatin induction chemotherapy followed by concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma. Participants will receive gemcitabine and cisplatin for two cycles before undergoing intensity-modulated radiotherapy (IMRT) alongside additional gemcitabine. The study aims to assess treatment efficacy using established evaluation standards and will monitor patients for up to three years post-treatment. A total of 65 patients will be enrolled, with careful monitoring for side effects and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma at stage III-IV.
Not a fit: Patients with a history of allergy to the treatment drugs or prior malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced nasopharyngeal carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar chemotherapy and radiotherapy combinations in treating nasopharyngeal carcinoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type) * Tumor staged as Ⅲ-Ⅳa (according to the 8th AJCC edition staging system) * Age :18-60 * Performance status: KPS \> 70 * 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 * Renal: creatinine clearance \> 60ml/min * Adequate marrow: leucocyte count \> 4×109/L, neutrophil count \> 2×109/L, and platelet count \> 100×109/L * Written informed consent Exclusion Criteria: * History of allergy to related drugs * Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) * History of previous RT (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
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: siyang wang — Fifth Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: qi zeng, Doctor
- Email: zengqi37@mail.sysu.edu.cn
- Phone: 18898534065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.