- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448522
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
September 24, 2020 updated by: Ming-Yuan Chen, Sun Yat-sen University
A Multicenter Randomized Controlled Trial Comparing Reduced Dose With Regular Dose Intensity-modulated Radiotherapy for Chemotherapy Sensitive Stage II-III Nasopharyngeal Carcinoma
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)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
508
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
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Guangzhou, Guangdong, China, 510095
- Not yet recruiting
- Cancer Center of Guangzhou Medical University
-
Contact:
- Dong-Ping Chen, MD
- Phone Number: 86-13302215492
- Email: chen_dpgz@163.com
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Principal Investigator:
- Dong-Ping Chen, MD
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Contact:
- Bin Qi, PhD
- Email: qibin020@126.com
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Shaoguan, Guangdong, China, 512025
- Not yet recruiting
- Yuebei People's Hospital
-
Contact:
- Su-Ming Pan, MD
- Phone Number: 86-13826331948
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Principal Investigator:
- Su-Ming Pan, MD
-
Contact:
- Xiang-Guo Zhang, MD
- Phone Number: 86-13826380511
- Email: 1178906911@qq.com
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Zhongshan, Guangdong, China, 528403
- Recruiting
- Zhongshan People's Hospital
-
Principal Investigator:
- Feng Lei, MD
-
Contact:
- Feng Lei, MD
- Phone Number: 86-18933345382
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-
Guangxi
-
Wuzhou, Guangxi, China, 543002
- Not yet recruiting
- Wuzhou Red Cross Hospital
-
Contact:
- Jin-Hui Liang, MD
- Phone Number: 86-13878480806
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Principal Investigator:
- Jin-Hui Liang, MD
-
-
-
-
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Singapore, Singapore, 169610
- Not yet recruiting
- National Cancer Centre Singapore
-
Contact:
- Melvin Lee Kiang Chua, PhD
- Phone Number: 65-6436-8000
- Email: melvin.chua.l.k@singhealth.com.sg
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Principal Investigator:
- Melvin Lee Kiang Chua, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reduced dosage IMRT group
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 63.6 Gy
|
|
Active Comparator: Conventional dosage IMRT group
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent cheomtherapy with IMRT dosage of 69.96 Gy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progress-free survival (PFS)
Time Frame: 3 years
|
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 3 years
|
Defined as the time interval from randomization to death due to any cause.
|
3 years
|
Distant Metastasis-Free Survival (DMFS)
Time Frame: 3 years
|
Defined as the time interval from randomisation to the date of first distant metastases.
|
3 years
|
Locoregional Relapse-Free Survival (LRRFS)
Time Frame: 3 years
|
Defined as the time from randomisation to the date of first locoregional relapse.
|
3 years
|
Incidence of treatment related acute complications
Time Frame: up to 1 years
|
The proportion of patients with treatment related acute complications according to NCI-CTC5.0
criteria and RTOG criteria.
|
up to 1 years
|
Incidence of treatment related late complications
Time Frame: up to 3 years
|
The proportion of patients with treatment related late complications according to NCI-CTC5.0
criteria and RTOG criteria.
|
up to 3 years
|
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time Frame: up to 3 years
|
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
|
up to 3 years
|
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time Frame: up to 3 years
|
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.
|
up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2020
Primary Completion (Anticipated)
August 1, 2026
Study Completion (Anticipated)
August 1, 2028
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (Actual)
June 26, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2020
Last Update Submitted That Met QC Criteria
September 24, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- SYSUCC-MYC-2020-1201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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