Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcinoma) to evaluate the safety and effectiveness of gemcitabine in patients with locally advanced nasopharyngeal carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
• Treatments: Gemcitabine

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