A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Nab-paclitaxel
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Sponsor
- Sun Yat-sen University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The maximum tolerated dose and the recommended phase II dose
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Fang-Yun Xie
professor
Sun Yat-sen University
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
Arms & Interventions
nab-paclitaxel arm
All patients enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively from 180 mg/m² to a maximum of 260 mg/m².
Intervention: Nab-paclitaxel
Outcomes
Primary Outcomes
The maximum tolerated dose and the recommended phase II dose
Time Frame: From start of radiotherapy to 2 weeks after completion of radiotherapy
The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.