Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
Sun Yat-sen University
454 participants
Sep 7, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria9
- 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 Criteria8
- 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.
Interventions
Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT05979961