Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Radiation: IMRT and concurrent cisplatin
- Registration Number
- NCT05979961
- Lead Sponsor
- Sun Yat-sen University
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 454
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMRT and concurrent cisplatin IMRT and concurrent cisplatin Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles. Induction chemotherapy+IMRT and concurrent cisplatin IMRT and concurrent cisplatin Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles. Induction chemotherapy+IMRT and concurrent cisplatin gemcitabine and cisplatin (Induction chemotherapy) Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
- Primary Outcome Measures
Name Time Method Progress-free survival(PFS) 3 years defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
- Secondary Outcome Measures
Name Time Method Overall response rate 16 weeks after completion of concurrent chemoradiotherapy Tumour response was classified according to RECIST, version 1.1
Overall survival(OS) 3 years defined as the time from random assignment to death from any cause.
Locoregional progression 3 years defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).
Incidence of acute and late toxicity 3 years Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Distant progression 3 years defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).
Trial Locations
- Locations (8)
Cancer Hospital of Guizhou Province
🇨🇳Guiyang, Guizhou, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Zhongshan City People's Hospital
🇨🇳Zhongshan, Guangdong, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Guangzhou Panyu Central Hospital
🇨🇳Guangzhou, Guangdong, China