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Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cisplatin,fluorouracil

Cisplatin

About this trial

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

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
No evidence of distant metastasis (M0)
Performance status: KPS ≥70
With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
Renal: creatinine clearance ≥60ml/min
Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
Written informed consent

Exclusion Criteria:

WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
Age ≥70 or <18
With a history of renal disease
Prior malignancy
Previous chemotherapy or radiotherapy
Patient is pregnant or lactating
Unstable cardiac disease requiring treatment.
Emotion disturbance

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent and adjuvant

Concurrent

Arm Description

Concurrent chemoradiotherapy plus adjuvant chemotherapy

Concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

Failure-free survival

Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Secondary Outcome Measures

Overall survival, distant failure-free survival and locoregional failure-free survival

Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.

Full Information

NCT ID

NCT00677118

First Posted

May 9, 2008

Last Updated

July 11, 2013

Sponsor

Sun Yat-sen University

Collaborators

Fudan University, Zhejiang Cancer Hospital, Huazhong University of Science and Technology, Fifth Affiliated Hospital, Sun Yat-Sen University, Peking University Cancer Hospital & Institute, Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00677118

Brief Title

Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

March 2015 (Anticipated)

Study Completion Date

March 2015 (Anticipated)

3. Sponsor/Collaborators

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 concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Detailed Description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received 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, Adjuvant 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

506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Concurrent and adjuvant

Arm Type

Experimental

Arm Description

Concurrent chemoradiotherapy plus adjuvant chemotherapy

Arm Title

Concurrent

Arm Type

Active Comparator

Arm Description

Concurrent chemoradiotherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin,fluorouracil

Other Intervention Name(s)

Cisplatin and fluorouracil

Intervention Description

Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.

Primary Outcome Measure Information:

Title

Failure-free survival

Description

Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Time Frame

2-yr

Secondary Outcome Measure Information:

Title

Overall survival, distant failure-free survival and locoregional failure-free survival

Description

Time Frame

2-yr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type) Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system) No evidence of distant metastasis (M0) Performance status: KPS ≥70 With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal) Renal: creatinine clearance ≥60ml/min Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL Written informed consent Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Age ≥70 or <18 With a history of renal disease Prior malignancy Previous chemotherapy or radiotherapy Patient is pregnant or lactating Unstable cardiac disease requiring treatment. Emotion 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

Citations:

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12833458

Citation

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Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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