Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315, China
NCT Number: NCT04528394
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 201315, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
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: From randomization to death, a median of 3 years.
Time frame: From randomization to death or disease progression, a median of 3 years.
Time frame: From randomization to local failure, a median of 3 years.
Time frame: From randomization to regional failure, a median of 3 years.
Time frame: From randomization to distant failure, a median of 3 year.
Time frame: Time interval from start to 3 months after completion of radiotherapy.
Acute and late toxicities induced by radiation therapy other than xerostomia.
Shanghai Proton and Heavy Ion Center
Other
A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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