Proton Therapy for Recurrent Nasopharyngeal Carcinoma
ConditionRecurrent Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Concord Cancer Center
About this trial
The above studies show that most of the supportive evidence for the reduction of toxicity and improvement of efficacy of proton therapy for recurrent Nasopharyngeal carcinoma(NPC) comes from various observational and retrospective studies, lacking high-level evidence-based medical evidence. The conduct of this study will explore the safety and efficacy of intensity-modulated proton radiotherapy for recurrent NPC and provide more high-quality evidence-based medical evidence for proton therapy of recurrent cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-metastatic squamous cell carcinoma of the nasopharynx with biopsy confirmation, at stage ≥ T2b and/or with positive lymph nodes, (2) Pathological type WHO I-III
PS score (according to Eastern Cooperative Oncology Group (ECOG) standard) 0-1.
Expected survival period ≥ 6 months
Before treatment, evaluate the tumor range and size of the patient.
Disqualifiers
Evidence of distant metastasis in stage IVc
Patients with isolated recurrence of cervical lymph nodes;
Patients have participated in other interventional trials for tumors
Having suffered from other malignant tumors within 5 years (excluding melanoma skin cancer) or tumors originating from the head and neck region Untreated active infections
Trial design
Design model
Single group
Treatments tested in this trial
Proton therapy
RadiationTreatment planning and target delineation: All patients were in the supine position with the head extended backward, with the mask fixed, and enhanced computed tomography (CT) scans were performed for positioning. The slice thickness was 1.25mm. The gross tumor volume (GTV) included the recurrent primary lesion. The clinical target volume (CTV) included the anatomical expansion of the tumor and the suspicious lesions visible under the microscope. The CTV was defined as an expansion of 5-10mm outside the GTV. Radiation dose and treatment plan: The prescribed dose was 60-66 Gray (Gy) delivered in 30-33 fractions. Plan design and dose verification: The physicist designed radiotherapy plans according to the requirements of the physician. After the radiotherapy plan was designed, it was evaluated and repeatedly optimized by the physician and the physicist until satisfactory results were achieved. Treatment: was required for each treatment session.
Proton radiation therapy
DeviceRadiation: Proton Therapy System (ProBeam)
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Proton therapy groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of severe late complications
The proportion of subjects whose toxicity reaction is level 3 during the clinical trial period. The researchers record AE that appeared during the clinical trial cycle and grade it according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
From enrollment to the three-year follow-up periodSecondary outcomes
1
Overall survival time
It is defined as the time interval from enrollment to the point of death due to any cause. If there is no death, it is calculated as the time of the last follow-up.
Time frame
From enrollment to the three-year follow-up period2
Local progression-free survival time
It is defined as the time interval from the start of the study to the occurrence of tumor progression or death due to any cause. If there is no tumor progression, it is calculated up to the last follow-up time.
Time frame
From enrollment to the three-year follow-up period3
Short-term treatment responses
The proportion of patients who achieved treatment response at the end of neoadjuvant chemotherapy and 3 months after the radiotherapy to evaluate the short-term therapeutic effect. Treatment response will be assessed according to the The Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Time frame
From enrollment to the three-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov