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Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Docetaxel, cisplatin and fluorouracil

Concurrent chemoradiotherapy

About this trial

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

Eligibility Criteria

18 Years - 59 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 T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
No evidence of distant metastasis (M0).
Satisfactory performance status: Karnofsky scale (KPS) > 70.
Adequate marrow: leucocyte count ≥4000/μL, 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

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction chemotherapy and concurrent chemoradiotherapy

Concurrent chemoradiotherapy

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

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

Outcomes

Primary Outcome Measures

Failure-free survival

Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Secondary Outcome Measures

Overall survival

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

Locoregional failure-free survival

The latency (ie, time from randomisation) to the first locoregional failure

Distant failure-free survival

The latency (ie, time from randomisation) to the first remote failure

The initial response rates after treatments

Toxic effects

Full Information

NCT ID

NCT01245959

First Posted

November 22, 2010

Last Updated

February 12, 2014

Sponsor

Sun Yat-sen University

Collaborators

Fudan University, West China Hospital, Huazhong University of Science and Technology, Peking University Cancer Hospital & Institute, Zhejiang Cancer Hospital, Central South University, Jiangsu Cancer Institute & Hospital, First People's Hospital of Foshan, The Third Affiliated Hospital of Harbin Medical University, Cancer Hospital of Guangxi Medical University, Jiangxi Provincial Cancer Hospital, Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01245959

Brief Title

Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

April 2016 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Detailed Description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm 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. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; 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, Concurrent chemoradiotherapy, Induction chemotherapy, Clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

476 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Induction chemotherapy and concurrent chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Concurrent chemoradiotherapy

Arm Type

Active Comparator

Arm Description

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

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

Failure-free survival

Description

Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

3-year

Title

Locoregional failure-free survival

Description

The latency (ie, time from randomisation) to the first locoregional failure

Time Frame

3-year

Title

Distant failure-free survival

Description

The latency (ie, time from randomisation) to the first remote failure

Time Frame

3-year

Title

The initial response rates after treatments

Time Frame

A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy

Title

Toxic effects

Time Frame

During and after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 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 T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition). No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/μL, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Ma, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

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

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Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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