Trial Title:
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
NCT ID:
NCT05979961
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Gemcitabine
Conditions: Keywords:
Nasopharyngeal Carcinoma
Induction Chemotherapy
Concurrent Chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
IMRT and concurrent cisplatin
Description:
Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during
Intensity modulated radiotherapy (IMRT)
Arm group label:
IMRT and concurrent cisplatin
Arm group label:
Induction chemotherapy+IMRT and concurrent cisplatin
Intervention type:
Drug
Intervention name:
gemcitabine and cisplatin (Induction chemotherapy)
Description:
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks
for 3 cycles before radiotherapy
Arm group label:
Induction chemotherapy+IMRT and concurrent cisplatin
Summary:
The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with
induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk
locoregionally advanced nasopharyngeal carcinoma(NPC).
Detailed description:
Patients with low risk NPC( Stage III-IVa, except T4N2/AnyTN3, AJCC 8th and EBV DNA <4000
copies/ml) are randomly assigned to receive CCRT alone or induction chemotherapy plus
CCRT. Patients in both groups receive cisplatin 100 mg/m² every 3 weeks for 3 cycles,
concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.12 Gy per
fraction with five daily fractions per week to a total dose of 70 Gy. The induction
chemotherapy plus CCRT group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m²
d1) every 3 weeks for three cycles before CCRT. Our primary endpoint is progress-free
survival. Secondary end points include overall survival (OS), Locoregional progression,
Distant progression and toxic effects. All efficacy analyses are conducted in the
intention-to-treat population, and the safety population include only patients who
receive their randomly assigned treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-70 years old.
2. Patients with newly histologically confirmed non-keratinizing (according to WHO
histologically type).
3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and
pretreatment plasm EB Virus DNA<4000copies/ml.
4. ECOG Performance status less or equal to 1.
5. Male and no pregnant female.
6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥
100000/μL.
7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate
Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline
phosphatase (ALP) < 2.5×ULN, and bilirubin < ULN.
8. Adequate renal function: creatinine clearance ≥ 60 ml/min.
9. Patients must be informed of the investigational nature of this study and give
written informed consent.
Exclusion Criteria:
1. Patients have evidence of relapse or distant metastasis.
2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
3. Treatment with palliative intent.
4. History of previous RT (except for non-melanomatous skin cancers outside intended RT
treatment volume).
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).
7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer,
in situ cervical cancer.
8. Any severe intercurrent disease, which may bring unacceptable risk or affect the
compliance of the trial, for example, unstable cardiac disease requiring treatment,
renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose
> 1.5×ULN), and emotional disturbance.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangzhou Panyu Central Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guo-Rong Zou, PhD
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Hai-Qiang Mai
Facility:
Name:
Zhongshan City People's Hospital
Address:
City:
Zhongshan
Zip:
528499
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feng Lei, MD
Phone:
13528227676
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ren-Sheng Wang, MD
Phone:
13807806008
Facility:
Name:
Cancer Hospital of Guizhou Province
Address:
City:
Guiyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feng Jin, PhD
Facility:
Name:
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Guang-Yuan Hu, PhD
Facility:
Name:
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kun-Yu Yang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Huai Liu, PhD
Start date:
September 7, 2023
Completion date:
September 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Collaborator:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou Panyu Central Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Cancer Hospital of Guizhou Province
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979961
