Combining nab-paclitaxel with radiation therapy for advanced nasopharyngeal carcinoma
A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
This study is testing different doses of nab-paclitaxel combined with radiation therapy to see if it can help people with advanced nasopharyngeal cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06611150 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify the maximum tolerated dose and the recommended phase II dose of nab-paclitaxel when given alongside intensity-modulated radiation therapy in patients with stage III-IVa nasopharyngeal carcinoma. Participants will receive varying doses of nab-paclitaxel (180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²) while being monitored for toxicity responses. The study focuses on understanding how this combination treatment can improve outcomes for patients with this type of cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed stage III-IVa nasopharyngeal carcinoma and a performance status score of 0-1.
Not a fit: Patients with other active malignancies, significant heart conditions, or those requiring systemic therapy for infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment efficacy and reduce toxicity for patients with advanced nasopharyngeal carcinoma.
How similar studies have performed: While this specific combination has not been extensively tested, concurrent chemotherapy and radiation therapy approaches have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Fang-Yun Xie
- Email: xiefy@sysucc.org.cn
- Phone: +8613902205880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.