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

NCT06611150 | Recruiting Phase 1

• 1 other identifier: B2024-076-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma; nab-paclitaxel; concurrent chemotherapy

Outcome Measures

Primary Outcomes (1)

• The maximum tolerated dose and the recommended phase II dose

  The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.

  From start of radiotherapy to 2 weeks after completion of radiotherapy

Study Arms (1)

nab-paclitaxel arm

EXPERIMENTAL

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.

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxel DRUG

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).

nab-paclitaxel arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed nasopharyngeal carcinoma
• III-IVa (AJCC8th)
• age 18-70
• PS score 0-1
• normal functions to tolerate chemotherapy and radiotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Fang-Yun Xie

CONTACT

+8613902205880; xiefy@sysucc.org.cn

Pu-Yun OuYang

CONTACT

ouyangpy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: August 2, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)