Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma (NPC). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Overview
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.
Interventions
- Drug Nab-paclitaxel
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).
Primary outcome measures
- The maximum tolerated dose and the recommended phase II dose [Time frame: From start of radiotherapy to 2 weeks after completion of radiotherapy]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06611150 · B2024-076-01