Status:
UNKNOWN
Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Researchers conduct the clinical trial (gemcitabine combined with cisplatin induction chemotherapy followed by concurrent chemoradiotherapy with gemcitabine for locally advanced nasopharyngeal carcino...
Detailed Description
Diagnosed as locally advanced nasopharyngeal carcinoma (stage III-IV), and pathologically confirmed as a differentiated or undifferentiated non-keratinizing nasopharyngeal carcinoma, the patient is el...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04522050
Start Date
October 1 2018
End Date
December 1 2024
Last Update
July 12 2023
Active Locations (1)
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1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000