Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Enrolling; Phase 1

Conditions: Nasopharyngeal Carcinoma (NPC)

Treatments: Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT06611150

B2024-076-01

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

nab-paclitaxel arm

Experimental group

Description:

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.

Treatment:

Drug: Nab-paclitaxel