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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
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  1. Only regionally recurrence
  2. Evidence of distant metastasis
  3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
  4. Severe, active co-morbidity
  5. Prior anti-tumor treatment after diagnosis of local recurrence
  6. MRI was not performed 3 months after the first course of radiotherapy
  7. Abnormal function of heart, brain and lungs, etc
  8. Lactation or pregnancy
  9. 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

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
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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
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
hanfei@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
hanyu wang, doctor
Phone
8620-87343418
Email
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
Email
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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