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Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC (NX-NPC)

Primary Purpose

Nasopharyngeal Carcinoma

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

docetaxel, nedaplatin, and capecitabine

nedaplatin

docetaxel, cisplatin, and fluorouracil

cisplatin

docetaxel, cisplatin, and capecitabine

docetaxel, nedaplatin, and fluorouracil

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Nedaplatin, Capecitabine

Eligibility Criteria

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

Inclusion Criteria:

Age 18-60
Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type)
Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
Tumor staged as American Joint Committee on Cance (AJCC) III-IVA (except T3-4N0)
Adequate marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L.
Normal liver and renal 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; 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.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
History of previous RT (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.
Patients who could not tolerate or allergic to capecitabine.
Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

A (TPF+P-RT)

B (TNF+N-RT)

C (TPX+P-RT)

D (TNX+N-RT)

Arm Description

Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin

Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin

Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin

Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin

Outcomes

Primary Outcome Measures

Progression-free survival

Progression-free survival is calculated from the date of randomisation to the date of disease progression or death from any cause, whichever is first.

Secondary Outcome Measures

Overall survival

Overall survival is calculated from randomization to death from any cause.

Distant failure-free survival

Distant failure-free survival is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

Locoregional failure-free survival

Locoregional failure-free survival is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (acute toxicity) and RTOG/EORTC (late toxicity)

Incidence of acute and late toxicity

Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30

QOL was assessed by EORTC QLQ-C30 during the treatment period

Full Information

NCT ID

NCT03503136

First Posted

April 6, 2018

Last Updated

May 4, 2018

Sponsor

Sun Yat-sen University

Collaborators

Tongji Hospital, Wuhan Union Hospital, China, Peking University, Air Force Military Medical University, China, Second Affiliated Hospital of Soochow University, The First Affiliated Hospital of Guangdong Pharmaceutical University, First People's Hospital of Foshan, Fifth Affiliated Hospital, Sun Yat-Sen University, Cancer Hospital of Guizhou Province, Xiangya Hospital of Central South University, Jilin Provincial Tumor Hospital, Henan Cancer Hospital, Hunan Cancer Hospital, Cancer Hospital of Guangxi Medical University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03503136

Brief Title

Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC

Acronym

NX-NPC

Official Title

Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC： a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2018 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of this study is to study the efficacy and safety of nedaplatin versus cisplatin, and capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF) plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced nasopharyngeal carcinoma (NPC).

Detailed Description

In this study, patients with non-keratinizing NPC and staged III-IVA (except T3-4N0) are randomly assigned to one of the four groups: Group A: TPF+P-RT; Group B: TNF+N-RT; Group C: TPX+P-RT; Group D: TNX+N-RT. In induction chemotherapy, patients will receive docetaxel(60 mg/m2 on day 1), cisplatin or nedaplatin (60 mg/m2 on day 1) and fluorouracil (600 mg/m2 on Days 1 to 5) or capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radical radiotherapy. Concurrent cisplatin or nedaplatin (100mg/m2 on day 1) was given every three weeks for two cycles during radiotherapy. Patients are stratified according to the treatment centers and stage. The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Nedaplatin, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

632 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A (TPF+P-RT)

Arm Type

Experimental

Arm Description

Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin

Arm Title

B (TNF+N-RT)

Arm Type

Experimental

Arm Description

Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin

Arm Title

C (TPX+P-RT)

Arm Type

Experimental

Arm Description

Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin

Arm Title

D (TNX+N-RT)

Arm Type

Experimental

Arm Description

Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin

Intervention Type

Drug

Intervention Name(s)

docetaxel, nedaplatin, and capecitabine

Other Intervention Name(s)

TNX induction chemotherapy

Intervention Description

Patients receive docetaxel(60 mg/m2 on day 1), nedaplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.

Intervention Type

Drug

Intervention Name(s)

nedaplatin

Other Intervention Name(s)

Intervention Description

Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.

Intervention Type

Drug

Intervention Name(s)

docetaxel, cisplatin, and fluorouracil

Other Intervention Name(s)

TPF induction chemotherapy

Intervention Description

Patients receive docetaxel (60mg/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 the radiotherapy.

Intervention Type

Drug

Intervention Name(s)

cisplatin

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

docetaxel, cisplatin, and capecitabine

Other Intervention Name(s)

TPX induction chemotherapy

Intervention Description

Patients receive docetaxel(60 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.

Intervention Type

Drug

Intervention Name(s)

docetaxel, nedaplatin, and fluorouracil

Other Intervention Name(s)

TNF induction chemotherapy

Intervention Description

Patients receive docetaxel (60mg/m2 on day 1), nedaplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival is calculated from the date of randomisation to the date of disease progression or death from any cause, whichever is first.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival is calculated from randomization to death from any cause.

Time Frame

3 years

Title

Distant failure-free survival

Description

Distant failure-free survival is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

Time Frame

3 years

Title

Locoregional failure-free survival

Description

Locoregional failure-free survival is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

Time Frame

3 years

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (acute toxicity) and RTOG/EORTC (late toxicity)

Description

Incidence of acute and late toxicity

Time Frame

Up to 3 years

Title

Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30

Description

QOL was assessed by EORTC QLQ-C30 during the treatment period

Time Frame

Up to 16 weeks

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: Age 18-60 Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type) Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1 Tumor staged as American Joint Committee on Cance (AJCC) III-IVA (except T3-4N0) Adequate marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L. Normal liver and renal 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; 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. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). History of previous RT (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. Patients who could not tolerate or allergic to capecitabine. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus.

Central Contact Person:

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

Jun Ma, M.D.

Phone

+86-20-87343469

majun2@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Principal Investigator Principal Investigator, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

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20643517

Citation

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Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC

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