Status:
UNKNOWN
Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) a...
Detailed Description
Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) a...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
- Original clinical staged as III-IVa （according to the 8th AJCC edition).
- No evidence of distant metastasis (M0).
- Male and no pregnant female.
- Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
- WBC ≥ 4×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L.
- With normal liver function test (ALT/AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN).
- With normal renal function test (Creatinine Clearance ≥ 60 ml/min ).
Exclusion
- Patients have evidence of relapse or distant metastasis.
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
- Receiving radiotherapy or chemotherapy previously.
- The presence of uncontrolled life-threatening illness.
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Receiving other ways of anti-cancer therapy.
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04850235
Start Date
April 15 2021
End Date
December 31 2024
Last Update
June 22 2023
Active Locations (1)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060