Back to resultsReduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Carcinoma, Radiotherapy, Chemotherapy
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
reduced dosage IMRT
conventional dosage IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, intensity-modulated radiotherapy, chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
- Aged between 18-70 years.
- Karnofsky scale (KPS)≥70.
- Normal bone marrow function.
- Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
- EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
Normal liver and kidney function:
- total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- Given written informed consent.
Exclusion Criteria:
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
- Recurrent or metastatic nasopharyngeal carcinoma.
- Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
- EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
- Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
- Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
- Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
- Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and mental illness.
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
- Cancer Center of Guangzhou Medical University
- Yuebei People's Hospital
- Zhongshan People's HospitalRecruiting
- Wuzhou Red Cross Hospital
- National Cancer Centre Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reduced dosage IMRT group
Conventional dosage IMRT group
Arm Description
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy
Outcomes
Primary Outcome Measures
Progress-free survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Secondary Outcome Measures
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Incidence of treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Incidence of treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.
Full Information
NCT ID
NCT04448522
First Posted
June 24, 2020
Last Updated
September 24, 2020
Sponsor
Sun Yat-sen University
Collaborators
National Cancer Centre, Singapore, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Yuebei People's Hospital, Wuzhou Red Cross Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04448522
Brief Title
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
Official Title
A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2020 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
National Cancer Centre, Singapore, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Yuebei People's Hospital, Wuzhou Red Cross Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that radiotherapy with reduced dose could significantly reduce the incidence of radiotherapy toxicities, improve the quality of life of patients while ensuring the tumor control rates for NPC patients staged as II-III who are sensitive to induction chemotherapy (imaging evaluation of CR/PR and EBV DNA copy number decreased to 0 copies/mL after induction chemotherapy)
Detailed Description
Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Radiotherapy, Chemotherapy
Keywords
Nasopharyngeal carcinoma, intensity-modulated radiotherapy, chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
508 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reduced dosage IMRT group
Arm Type
Experimental
Arm Description
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy
Arm Title
Conventional dosage IMRT group
Arm Type
Active Comparator
Arm Description
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy
Intervention Type
Radiation
Intervention Name(s)
reduced dosage IMRT
Intervention Description
Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
IMRT: PTVnx：63.6Gy/30Fr/2.12Gy; PTVnd：63.6Gy/30Fr/2.12Gy; PTV1：54Gy/30Fr/1.8Gy; PTV2：49.2Gy/30Fr/1.64Gy
Intervention Type
Radiation
Intervention Name(s)
conventional dosage IMRT
Intervention Description
Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
IMRT: PTVnx：69.96Gy/33Fr/2.12Gy; PTVnd：69.96Gy/33Fr/2.12Gy; PTV1：59.4Gy/33Fr/1.8Gy; PTV2：54Gy/33Fr/1.64Gy
Primary Outcome Measure Information:
Title
Progress-free survival (PFS)
Description
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Defined as the time interval from randomization to death due to any cause.
Time Frame
3 years
Title
Distant Metastasis-Free Survival (DMFS)
Description
Defined as the time interval from randomisation to the date of first distant metastases.
Time Frame
3 years
Title
Locoregional Relapse-Free Survival (LRRFS)
Description
Defined as the time from randomisation to the date of first locoregional relapse.
Time Frame
3 years
Title
Incidence of treatment related acute complications
Description
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time Frame
up to 1 years
Title
Incidence of treatment related late complications
Description
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Time Frame
up to 3 years
Title
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Description
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time Frame
up to 3 years
Title
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Description
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.
Time Frame
up to 3 years
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:
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
Aged between 18-70 years.
Karnofsky scale (KPS)≥70.
Normal bone marrow function.
Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
Normal liver and kidney function:
total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
Given written informed consent.
Exclusion Criteria:
Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
Recurrent or metastatic nasopharyngeal carcinoma.
Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5×ULN), and mental illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-87343624
Email
chmingy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Rui You, MD, PhD
Phone
86-13580439820
Email
yourui@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-8734-3361
Email
chmingy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Rui You, MD, PhD
Phone
86-13580439820
Email
yourui@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510095
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Ping Chen, MD
Phone
86-13302215492
Email
chen_dpgz@163.com
First Name & Middle Initial & Last Name & Degree
Bin Qi, PhD
Email
qibin020@126.com
First Name & Middle Initial & Last Name & Degree
Dong-Ping Chen, MD
Facility Name
Yuebei People's Hospital
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su-Ming Pan, MD
Phone
86-13826331948
First Name & Middle Initial & Last Name & Degree
Xiang-Guo Zhang, MD
Phone
86-13826380511
Email
1178906911@qq.com
First Name & Middle Initial & Last Name & Degree
Su-Ming Pan, MD
Facility Name
Zhongshan People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528403
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Lei, MD
Phone
86-18933345382
First Name & Middle Initial & Last Name & Degree
Feng Lei, MD
Facility Name
Wuzhou Red Cross Hospital
City
Wuzhou
State/Province
Guangxi
ZIP/Postal Code
543002
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Hui Liang, MD
Phone
86-13878480806
First Name & Middle Initial & Last Name & Degree
Jin-Hui Liang, MD
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melvin Lee Kiang Chua, PhD
Phone
65-6436-8000
Email
melvin.chua.l.k@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Melvin Lee Kiang Chua, PhD
12. IPD Sharing Statement
Learn more about this trial
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
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