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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

The Efficacy and Safety of Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil, Concurrent Chemotherapy of Cisplatin and IMRT in Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective, Multi-centeric, Open, Non-controlled, Phase II Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04004871
• Other study ID #: GuangxiMUHK1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 5, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2019
• Source: Guangxi Medical University
• Contact: Kai Hu
• Phone: +8613907710887
• Email: gxhukai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Nasopharynx Cancer

Intervention

Drug:
• Nab-paclitaxel, Cisplatin and Fluorouracil
Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.

Radiation:
• concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Guangxi Medical University	Guilin Medical University, China, Liuzhou Worker's Hospital, Second affiliated hospital of Guangxi Medical University, Wuzhou Red Cross Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	To be determined by measurement of target lesions according to RECIST criteria	3 years
Secondary	Failure-free survival (FFS)	From the date of registration to the date of either locally, regionally or distant failure or last follow-up	3 years
Secondary	Overall survival(OS)	From the date of registration to the date of death is observed or to last follow-up visit	3 years
Secondary	Adverse Events	Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03	3 years