Actively Recruiting
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2020-09-28
508
Participants Needed
6
Research Sites
415 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
N
National Cancer Centre, Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III)
- Stage II-III disease (T1-3N1-2M0 or T2-3N0M0) according to the 8th AJCC edition
- Age between 18 and 70 years
- Karnofsky performance score of 70 or higher
- Normal bone marrow function
- Partial or complete response after 3 cycles of gemcitabine plus cisplatin induction chemotherapy
- Epstein-Barr virus (EBV) DNA decreased to 0 copies/mL after induction chemotherapy
- Normal liver function with total bilirubin, AST, and ALT levels no more than 2.5 times the upper normal limit
- Normal kidney function with creatinine clearance rate at least 60 mL/min or creatinine no more than 1.5 times the upper normal limit
- Provided written informed consent
You will not qualify if you...
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma
- Recurrent or metastatic nasopharyngeal carcinoma
- Stable disease or progressive disease after 3 cycles of gemcitabine plus cisplatin induction chemotherapy
- Epstein-Barr virus (EBV) DNA more than 0 copies/mL after induction chemotherapy
- Pregnancy or breastfeeding
- Other invasive cancers in the past except cured basal cell skin carcinoma, squamous cell carcinoma, or cervical carcinoma in situ
- Prior chemotherapy or surgery for primary and regional lesions except for diagnosis
- Severe diseases that increase risk or affect participation, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, or mental illness
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
Not Yet Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Actively Recruiting
5
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Not Yet Recruiting
6
National Cancer Centre Singapore
Singapore, Singapore, 169610
Not Yet Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
R
Rui You, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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