Status:
UNKNOWN
Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
Lead Sponsor:
Shanghai Proton and Heavy Ion Center
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 b...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- Age ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group score: 0-1.
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil \> 2000/mm\^3; 2) platelet \> 100,000/mm\^3; 3) total bilirubin \< 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase \< 1.5 upper limit of normal; 5) SCr \< 1.5mg/dl; creatinine clearance rate \> 60ml/min.
- Willing to accept adequate contraception for women with childbearing potential.
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
Exclusion
- Presence of distant metastasis.
- Received radiotherapy for head and neck before.
- Received surgery(except for biopsy) for primary lesion or cervical lymph node.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
- Accompanied with severe major organ dysfunction.
- Presence of mental disease that may influence the understanding of informed consent.
Key Trial Info
Start Date :
April 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04528394
Start Date
April 29 2019
End Date
June 30 2022
Last Update
August 27 2020
Active Locations (1)
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1
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China, 201315