Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

Last updated: July 1, 2019
Sponsor: Guangxi Medical University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Nasopharyngeal Cancer

Carcinoma

Treatment

N/A

Clinical Study ID

NCT04004871
GuangxiMUHK1
  • Ages 18-60
  • All Genders

Study Summary

Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25‑50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing (according to WorldHealth Organization (WHO) histologically type).

  2. Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).

  3. No evidence of distant metastasis (M0).

  4. EBV positive.

  5. Satisfactory performance status: ECOG≤2.

  6. Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

  7. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.

  8. Adequate renal function: creatinine clearance ≥60 ml/min.

  9. Patients must be informed of the investigational nature of this study and give writteninformed consent.

Exclusion

Exclusion Criteria:

  1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

  2. Age＞60 years or <18 years.

  3. Treatment with palliative intent.

  4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, insitu cervical cancer.

  5. Pregnancy or lactation.

  6. History of previous radiotherapy (except for non-melanomatous skin cancers outsideintended RT treatment volume).

  7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

  8. Any severe intercurrent disease, which may bring unacceptable risk or affect thecompliance of the trial, for example, unstable cardiac disease requiring treatment,renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Study Design

Total Participants: 60
Study Start date:
July 05, 2019
Estimated Completion Date:
June 30, 2022