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Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma (IMRT)

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cisplatin

IMRT

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring concurrent chemotherapy, IMRT, recurrent NPC

Eligibility Criteria

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

Inclusion Criteria:

1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
2.No evidence of distant metastasis
3.More than 1 year from the end of the first course of radiotherapy
4.Male, or female not in the phase of lactating or pregnancy
5.ECOG 0-2
6.Aged 18-70 years old
7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
9.Written informed consort signed

Exclusion Criteria:

Only regionally recurrence
Evidence of distant metastasis
Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
Severe, active co-morbidity
Prior anti-tumor treatment after diagnosis of local recurrence
MRI was not performed 3 months after the first course of radiotherapy
Abnormal function of heart, brain and lungs, etc
Lactation or pregnancy
Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Sites / Locations

WangHanYuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IMRT and concurrent cisplatin

IMRT alone

Arm Description

IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction

IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Number of participants with severe acute toxicities as assessed by CTCAE v3.0

Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

Full Information

NCT ID

NCT04136886

First Posted

October 22, 2019

Last Updated

October 22, 2019

Sponsor

Sun Yat-sen University

Collaborators

JiangXi Province Tumor Hospital, Fujian Province Tumor Hospital, SiChuan Province Tumor Hospital, Hunan Province Tumor Hospital, YuNan Province Tumor Hospital, GuiZhou Province Tumor Hospital, Hainan Cancer Hospital, Tongji Hospital, Second Affiliated Hospital of Nanchang University, Wuhan University, First Hospital of FoShan City

1. Study Identification

Unique Protocol Identification Number

NCT04136886

Brief Title

Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Acronym

IMRT

Official Title

Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Anticipated)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (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

5. Study Description

Brief Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Detailed Description

Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

concurrent chemotherapy, IMRT, recurrent NPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT and concurrent cisplatin

Arm Type

Active Comparator

Arm Description

IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction

Arm Title

IMRT alone

Arm Type

Experimental

Arm Description

IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Intervention Type

Radiation

Intervention Name(s)

IMRT

Intervention Description

Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

From the beginning the IMRT to 3 year after the end of IMRT

Secondary Outcome Measure Information:

Title

Number of participants with severe acute toxicities as assessed by CTCAE v3.0

Time Frame

From the beginning of IMRT to 3 months after the end of IMRT

Title

Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

Time Frame

From 3 months after the end of IMRT to 1 year after the end of IMRT

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: 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma; 2.No evidence of distant metastasis 3.More than 1 year from the end of the first course of radiotherapy 4.Male, or female not in the phase of lactating or pregnancy 5.ECOG 0-2 6.Aged 18-70 years old 7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L 8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits 9.Written informed consort signed Exclusion Criteria: Only regionally recurrence Evidence of distant metastasis Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted Severe, active co-morbidity Prior anti-tumor treatment after diagnosis of local recurrence MRI was not performed 3 months after the first course of radiotherapy Abnormal function of heart, brain and lungs, etc Lactation or pregnancy Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Central Contact Person:

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

Fei Han, doctor

Phone

8620-87343030

hanfei@sysucc.org.cn

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

hanyu wang, doctor

Phone

8620-87343418

wanghany@sysucc.org.cn

Facility Information:

Facility Name

WangHanYu

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HanYu wang, PHD

Phone

008613925186898

why716@21cn.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

22209574

Citation

Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.

Results Reference

background

PubMed Identifier

21509764

Citation

Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16.

Results Reference

background

PubMed Identifier

19919887

Citation

Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16.

Results Reference

background

PubMed Identifier

26879049

Citation

Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016 Feb 15;35:20. doi: 10.1186/s40880-016-0081-7.

Results Reference

result

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Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

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