Actively Recruiting
A Prospective Phase II Clinical Study of Proton Therapy for Recurrent Nasopharyngeal Carcinoma
Led by Guangzhou Concord Cancer Center · Updated on 2026-03-09
52
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of intensity-modulated proton radiotherapy for patients with recurrent nasopharyngeal carcinoma (NPC) that cannot be removed by surgery. This study aims to provide high-quality evidence to support proton therapy as a treatment option for recurrent NPC, addressing the limitations of current treatments like intensity-modulated radiotherapy (IMRT), which may cause severe side effects and have limited survival rates. The study is a prospective clinical trial focusing on improving treatment outcomes and reducing complications for this patient group. Participants will receive proton therapy using a precise treatment plan designed to target tumors while sparing nearby healthy tissues. The prescribed radiation dose ranges from 60 to 66 Gray (Gy), delivered in 30 to 33 sessions over 6 to 6.5 weeks, with treatments given five days per week. The therapy involves careful imaging and planning to define tumor areas and suspicious lesions, followed by treatment sessions using a Proton Therapy System (ProBeam). During the study, participants will undergo evaluations of tumor control, survival, and potential side effects from enrollment through a three-year follow-up. Researchers will monitor severe late complications, overall survival time, and local progression-free survival time. Short-term treatment responses will also be assessed up to three months after treatment. This comprehensive monitoring will help determine the benefits and risks of proton therapy for recurrent NPC patients over an extended period.
CONDITIONS
Brief Title
Proton Therapy for Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Non-metastatic squamous cell carcinoma of the nasopharynx confirmed by biopsy
- Tumor stage T2b or higher and/or positive lymph nodes
- Pathological type WHO I-III
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 6 months
- Tumor range and size evaluated before treatment
- Good nutritional and physical condition able to tolerate radiotherapy and chemotherapy
You will not qualify if you...
- Evidence of distant metastasis (stage IVc)
- Isolated recurrence of cervical lymph nodes
- Participation in other interventional tumor trials
- History of other malignant tumors within 5 years (except melanoma skin cancer)
- Untreated active infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 6.5 weeks
Participants receive proton therapy with a prescribed dose of 60-66 Gy delivered in 30-33 fractions over 6 to 6.5 weeks.
5 visits per week for 6 to 6.5 weeks (in-person treatment sessions)
Duration - Up to 3 years
Participants are monitored for treatment response and long-term safety, including the incidence of severe late complications and overall survival.
Regular follow-up visits during the 3-year post-treatment period
Trial Site Locations
Total: 2 locations
1
Guangzhou Concord Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
2
Guangzhou concord cancer center
Guanzhou, Guangzhou, China
Actively Recruiting
Research Team
T
Taize Yuan, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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