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

Phase 2

• Conditions: Nasopharynx Cancer; Nasopharyngeal Carcinoma; Nasopharyngeal Cancer
• Interventions: Drug: Nab-paclitaxel, Cisplatin and Fluorouracil; Radiation: concurrent chemoradiotherapy

• Registration Number: NCT04004871
• Lead Sponsor: Guangxi Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-07-05
• Last Update Posted: 2019-07-05
• Primary Completion: 2019-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing (according to World Health 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 written informed consent.

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, in situ cervical cancer.
5. Pregnancy or lactation.
6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended 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 the compliance 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Induction chemotherapy and concurrent chemoradiotherapy	Nab-paclitaxel, Cisplatin and Fluorouracil	Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.
Induction chemotherapy and concurrent chemoradiotherapy	concurrent chemoradiotherapy	Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	3 years	To be determined by measurement of target lesions according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Overall survival（OS）	3 years	From the date of registration to the date of death is observed or to last follow-up visit
Failure-free survival (FFS)	3 years	From the date of registration to the date of either locally, regionally or distant failure or last follow-up
Adverse Events	3 years	Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03