Status:
RECRUITING
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First Affiliated Hospital of Guangxi Medical University
Zhongshan People's Hospital, Guangdong, China
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 nasoph...
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 ...
Eligibility Criteria
Inclusion
- Age 18-70 years old.
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
- ECOG Performance status less or equal to 1.
- Male and no pregnant female.
- Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
- 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.
- Adequate renal function: creatinine clearance ≥ 60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- Patients have evidence of relapse or distant metastasis.
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent.
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- 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.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
454 Patients enrolled
Trial Details
Trial ID
NCT05979961
Start Date
September 7 2023
End Date
September 1 2029
Last Update
August 6 2024
Active Locations (8)
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1
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
3
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528499
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021