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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06611150
Enrollment
24
Registered
2024-09-24
Start date
2024-08-02
Completion date
2027-08-01
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma, nab-paclitaxel, concurrent chemotherapy

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.

Interventions

DRUGNab-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).

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The maximum tolerated dose and the recommended phase II doseFrom start of radiotherapy to 2 weeks after completion of radiotherapyThe maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.

Countries

China

Contacts

Primary ContactFang-Yun Xie
xiefy@sysucc.org.cn+8613902205880
Backup ContactPu-Yun OuYang
ouyangpy@sysucc.org.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026