Actively Recruiting
A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-09-27
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying nasopharyngeal carcinoma (NPC) to find the maximum tolerated dose and the recommended phase II dose of nab-paclitaxel when given together with radiotherapy. This phase I clinical trial focuses on patients with stage III to IVa NPC, aiming to carefully observe how patients respond to different doses of nab-paclitaxel during treatment. All participants will receive nab-paclitaxel during radical radiotherapy following induction chemotherapy. The study gradually increases the doses from 180 mg/m8 to 260 mg/m8, monitoring patients closely throughout the treatment period to assess tolerance and side effects. Participants will be involved from the start of radiotherapy until two weeks after its completion. Researchers will track the maximum tolerated dose and recommend the best dose for future studies. Throughout the trial, patients will undergo regular assessments to monitor their response and safety during and after treatment.
CONDITIONS
Brief Title
Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed nasopharyngeal carcinoma
- Stage III-IVa according to AJCC 8th edition
- Age between 18 and 70 years
- Performance status score of 0 or 1
- Normal organ functions to tolerate chemotherapy and radiotherapy
You will not qualify if you...
- Presence of other malignant cancers within the past five years, except treated carcinoma in situ, non-melanoma skin cancer, or papillary thyroid cancer
- Symptomatic heart failure or unstable angina
- Recent myocardial infarction
- Active infections requiring systemic treatment
- Psychiatric disorders or social/family factors affecting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From start of radiotherapy to 2 weeks after completion of radiotherapy
Participants receive nab-paclitaxel concurrently with intensity-modulated radiation therapy following induction chemotherapy. The doses of nab-paclitaxel are progressively increased.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fang-Yun Xie
P
Pu-Yun OuYang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here