A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma

Phase 1

Recruiting

• Conditions: Nasopharyngeal Carcinoma (NPC)
• Interventions: Drug: Nab-paclitaxel

• Registration Number: NCT06611150
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-02
• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2025-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nab-paclitaxel arm	Nab-paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
The maximum tolerated dose and the recommended phase II dose	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.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China