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Trial Title:
Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
NCT ID:
NCT06611150
Condition:
Nasopharyngeal Carcinoma (NPC)
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Paclitaxel
Conditions: Keywords:
nasopharyngeal carcinoma
nab-paclitaxel
concurrent chemotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Nab-paclitaxel
Description:
All participants enrolled in the study will be treated with nab-paclitaxel during radical
radiotherapy following induction chemotherapy. The doses are increased progressively (180
mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²).
Arm group label:
nab-paclitaxel arm
Summary:
The goal of this clinical trial is to determine the maximum tolerated dose and the
recommended phase II dose for nab-paclitaxel when administered concurrently with
radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response
of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed nasopharyngeal carcinoma
- III-IVa (AJCC8th)
- age 18-70
- PS score 0-1
- normal functions to tolerate chemotherapy and radiotherapy
Exclusion Criteria:
- The presence of other malignant neoplasms within the preceding five years, with the
exception of carcinoma in situ, adequately treated non-melanoma skin cancer and
papillary thyroid cancer, is permitted.
- Symptomatic heart failure, unstable angina, myocardial infarction, active infections
requiring systemic therapy, psychiatric disorders, or family and social factors
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang-Yun Xie
Phone:
+8613902205880
Email:
xiefy@sysucc.org.cn
Contact backup:
Last name:
Pu-Yun OuYang
Email:
ouyangpy@sysucc.org.cn
Contact backup:
Last name:
Fang-Yun Xie
Start date:
August 2, 2024
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06611150
