The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent \[GyE\]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Photon combined with Carbon ion in Arm 1
Proton combined with Carbon ion in Arm 2
Same dose and fractionation will be used in both arms.
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
Time frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
Overall survival of all patients
Time frame: From randomization to death, a median of 3 years.
Progression-free survival of all patients
Time frame: From randomization to death or disease progression, a median of 3 years.
Local control
Time frame: From randomization to local failure, a median of 3 years.
Regional control
Time frame: From randomization to regional failure, a median of 3 years.
Distant control
Time frame: From randomization to distant failure, a median of 3 year.
Treatment-related adverse events as assessed by NCI CTCAE v4.03
Acute and late toxicities induced by radiation therapy other than xerostomia.
Time frame: Time interval from start to 3 months after completion of radiotherapy.
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