Reduced vs Conventional Dosage Intensity-modulated Radiotherapy for Chemotherapy-sensitive Stage II-III Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Aug 25, 2028
  • participants needed
    508
  • sponsor
    Sun Yat-sen University
Updated on 25 January 2021
carcinoma
karnofsky performance status
iv infusion
induction chemotherapy
gemcitabine
chemotherapy regimen
administration intravenous
intensity-modulated radiation therapy
creatinine clearance rate
nasopharyngeal carcinoma
ebv dna
epstein-barr virus deoxyribonucleic acid
epstein-barr virus dna

Summary

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)

Description

Through multicenter, open-label, randomised clinical trials, patients with NPC staged as II-III with CR/PR according to RECIST criteria and EBV DNA decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy will be randomized into experimental group to receive IMRT of reduced dose (prescribed dose, 63.6 Gy, 2.12 Gy per fractions, 30 fractions) and control group to receive IMRT of conventional dose (prescribed dose, 69.96 Gy, 2.13 Gy per time, 33 fractions). Two cycles of cisplatin chemotherapy will be performed during IMRT. The efficacy, toxicity, and quality of life of patients between the two groups will be compared.

Details
Condition Chemotherapy, Chemotherapy, Radiation Oncology, Carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, drug therapy, Radiotherapy, radiotherapeutic, Nasopharyngeal Cancer, Nasopharyngeal Cancer, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, nasopharyngeal carcinoma, chemotherapy regimen, cancer chemotherapy, chemotherapy regimens, pharmacological treatment, treatment with medication, medication therapy, drug therapies, pharmacotherapies
Treatment reduced dosage IMRT, conventional dosage IMRT
Clinical Study IdentifierNCT04448522
SponsorSun Yat-sen University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III)
Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition)
Aged between 18-70 years
Karnofsky scale (KPS)70
Normal bone marrow function
Evaluated as PR or CR after 3 cycles of GP induction chemotherapy
EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy
Normal liver and kidney function
total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit
creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit
Given written informed consent

Exclusion Criteria

Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma
Recurrent or metastatic nasopharyngeal carcinoma
Evaluated as SD or PD after 3 cycles of GP induction chemotherapy
EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy
Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ
Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose > 1.5ULN), and mental illness
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