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

Primary Purpose

Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Nab-paclitaxel, Cisplatin and Fluorouracil

concurrent chemoradiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).
No evidence of distant metastasis (M0).
EBV positive.
Satisfactory performance status: ECOG≤2.
Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
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.
Adequate renal function: creatinine clearance ≥60 ml/min.
Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age>60 years or <18 years.
Treatment with palliative intent.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation.
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction chemotherapy and concurrent chemoradiotherapy

Arm Description

Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

To be determined by measurement of target lesions according to RECIST criteria

Secondary Outcome Measures

Failure-free survival (FFS)

From the date of registration to the date of either locally, regionally or distant failure or last follow-up

Overall survival（OS）

From the date of registration to the date of death is observed or to last follow-up visit

Adverse Events

Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03

Full Information

NCT ID

NCT04004871

First Posted

June 26, 2019

Last Updated

July 1, 2019

Sponsor

Guangxi Medical University

Collaborators

Second Affiliated Hospital of Guangxi Medical University, Guilin Medical University, China, Liuzhou Workers Hospital, Wuzhou Red Cross Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04004871

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 5, 2019 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

Collaborators

Second Affiliated Hospital of Guangxi Medical University, Guilin Medical University, China, Liuzhou Workers Hospital, Wuzhou Red Cross Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Nasopharyngeal Cancer, Nasopharynx Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Induction chemotherapy and concurrent chemoradiotherapy

Arm Type

Experimental

Arm Description

Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel, Cisplatin and Fluorouracil

Other Intervention Name(s)

APF induction chemotherapy

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

concurrent chemoradiotherapy

Other Intervention Name(s)

Radical radiotherapy and concurrent cisplatin

Intervention Description

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

To be determined by measurement of target lesions according to RECIST criteria

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Failure-free survival (FFS)

Description

From the date of registration to the date of either locally, regionally or distant failure or last follow-up

Time Frame

3 years

Title

Overall survival（OS）

Description

From the date of registration to the date of death is observed or to last follow-up visit

Time Frame

3 years

Title

Adverse Events

Description

Incidence of Treatment-Emergent Adverse Events Evaluated according to NCI-CTC AE V4.03

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). Tumor staged as T3-4/N1-3 (according to the 8th UICC edition). No evidence of distant metastasis (M0). EBV positive. Satisfactory performance status: ECOG≤2. Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL. 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. Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Age>60 years or <18 years. Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Hu

Phone

+8613907710887

gxhukai@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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