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Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Primary Purpose

Local Advanced High Risk Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

IMRT combine with cisplatin concurrent chemotherapy

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

About this trial

This is an interventional treatment trial for Local Advanced High Risk Nasopharyngeal Carcinoma focused on measuring Local advanced, high risk, nasopharyngeal carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
Clinical stage III~IVb(UICC 7th)
Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l
Range from 18～70 years old
WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
OSerum creatinine < 1.5×ULN

Exclusion Criteria:

Central nervous system metastases
Suitable for local treatment
Uncontrolled seizure disorder or other serious neurologic disease
Clinically significant cardiac or respiratory disease
Drug or alcohol addition
Do not have full capacity for civil acts
Severe complication, active infection
Concurrent immunotherapy or hormone therapy for other diseases
Pregnancy or lactation

Sites / Locations

Cancer Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent chemoradiation + adjuvant chemotherapy

Concurrent chemoradiation

Arm Description

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

IMRT combine with cisplatin concurrent chemotherapy

Outcomes

Primary Outcome Measures

Failure free survival

Defined as the time from date of recruitment to documented relapse or death from any cause.

Secondary Outcome Measures

Acute Toxicity

To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Full Information

NCT ID

NCT02143388

First Posted

May 7, 2014

Last Updated

August 30, 2022

Sponsor

Zhao Chong

Collaborators

Jiangxi Provincial Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02143388

Brief Title

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Official Title

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

March 31, 2014 (Actual)

Primary Completion Date

July 27, 2018 (Actual)

Study Completion Date

August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhao Chong

Collaborators

Jiangxi Provincial Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, National Cancer Centre, Singapore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

6. Conditions and Keywords

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

Local Advanced High Risk Nasopharyngeal Carcinoma

Keywords

Local advanced, high risk, nasopharyngeal carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Concurrent chemoradiation + adjuvant chemotherapy

Arm Type

Experimental

Arm Description

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Arm Title

Concurrent chemoradiation

Arm Type

Active Comparator

Arm Description

IMRT combine with cisplatin concurrent chemotherapy

Intervention Type

Drug

Intervention Name(s)

IMRT combine with cisplatin concurrent chemotherapy

Intervention Description

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

Intervention Type

Drug

Intervention Name(s)

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Intervention Description

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Primary Outcome Measure Information:

Title

Failure free survival

Description

Defined as the time from date of recruitment to documented relapse or death from any cause.

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Acute Toxicity

Description

To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Locoregional relapse free survival

Description

Defined as the time from date of recruitment to documented locoregional relapse or death from any cause.

Time Frame

3-year

Title

Distance metastasis free survival

Description

Defined as the time from date of recruitment to documented distant metastatic recurrence or death from any cause.

Time Frame

3-year

Title

Overall survival rate

Description

Defined as the time from date of recruitment to death from any cause.

Time Frame

3-year

Title

Late Toxicity

Description

To evaluate the late toxicity with the RTOG/EORTC criterion when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III) Clinical stage III~IVb(UICC 7th) Meet at least one factor below :1 primary tumor SUVmax>10 in 18F-FDG PET/CT;2 primary tumor volume>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA>2×10E4 copy/l Range from 18～70 years old WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN OSerum creatinine < 1.5×ULN Exclusion Criteria: Central nervous system metastases Suitable for local treatment Uncontrolled seizure disorder or other serious neurologic disease Clinically significant cardiac or respiratory disease Drug or alcohol addition Do not have full capacity for civil acts Severe complication, active infection Concurrent immunotherapy or hormone therapy for other diseases Pregnancy or lactation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhao chong, M.D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

36227615

Citation

Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.

Results Reference

derived

Links:

URL

http://www.sysucc.org.cn

Description

Home Page of Cancer Center, Sun Yat-sen University

Learn more about this trial

Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

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