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Proton Therapy for Recurrent Nasopharyngeal Carcinoma

A Prospective Phase II Clinical Study of Proton Therapy for Recurrent Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07412314
Enrollment
52
Registered
2026-02-17
Start date
2025-03-10
Completion date
2028-03-10
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

proton therapy, recurrent nasopharyngeal carcinoma

Brief summary

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.

Detailed description

Radiotherapy is the main treatment for nasopharyngeal carcinoma (NPC). Currently, the 5-year local control rate for NPC is 80% to 85% . However, some patients inevitably experience local recurrence. For early recurrent tumors, salvage surgery can achieve satisfactory tumor control and improve the quality of life for patients, thus being a reasonable treatment option. However, many recurrent tumors are too advanced to be resected. For these unresectable tumors, high-dose re-irradiation is the only potentially curative method. Intensity-modulated radiotherapy (IMRT), as the main treatment for NPC, has achieved encouraging results in local control, survival, and tolerable toxicity. However, there are still two problems with the treatment plan of IMRT for unresectable recurrent NPC: first, the survival of patients is still poor. It has been reported that the 2-year local progression-free survival rate of locally recurrent NPC patients treated with IMRT combined with chemotherapy is approximately 56% to 76.9%, and the 2-year overall survival rate is only 44% to 68%. Second, severe adverse reactions caused by re-irradiation are the most important cause of treatment failure. About 64.9% of patients experience grade 3 to 5 late radiation-related toxicities such as mucosal necrosis and temporal lobe necrosis . Therefore, in recent years, researchers have been trying more advanced radiotherapy techniques to improve the efficacy of patients with unresectable locally recurrent NPC and reduce radiotherapy-related complications. Proton radiotherapy is currently recognized as the cutting-edge radiotherapy technology internationally, mainly through particle beam irradiation of tumors. Particles enter with low energy and gradually increase energy deposition until a rapid increase occurs within the "Bragg peak", that is, the energy is elevated and released entirely when reaching the tumor site, achieving a "directed explosion" on the tumor, and then rapidly decreases after passing through the tumor site, decaying to 0 within a very short distance, resulting in minimal radiation to the surrounding normal tissues and reducing the occurrence of long-term adverse reactions. Therefore, proton radiotherapy is an ideal and preferred choice for recurrent NPC. However, there are currently few studies on proton and heavy ion therapy for recurrent NPC, and most are retrospective and observational studies. Although some studies have included patients with unresectable locally recurrent NPC who received re-irradiation with protons, they have not provided detailed information on the specific outcomes of these patients . On the other hand, Linda et al.'s historical study reported that the 2-year overall survival (OS) and local progression-free survival rates of 16 patients with recurrent NPC who received proton beam re-irradiation (median dose of 60.1 Gy relative biological effectiveness (RBE)) were both 50%, and it caused minimal side effects on the central nervous system. Meanwhile, Dionisi et al. reported that 17 patients (12 of whom were rT4 patients) received proton re-irradiation, with a median follow-up of 10 months: 23.5% of the patients experienced grade ≥ 3 late toxicities; the 18-month OS and local control rates were 54.4% and 66.6%, respectively. The above studies show that most of the supportive evidence for the reduction of toxicity and improvement of efficacy of proton therapy for recurrent 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.

Interventions

RADIATIONProton therapy

Treatment 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.

Radiation: Proton Therapy System (ProBeam)

Sponsors

Guangzhou Concord Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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 2. PS score (according to Eastern Cooperative Oncology Group (ECOG) standard) 0-1. Age ≥ 18 years. 3. Expected survival period ≥ 6 months 4. Before treatment, evaluate the tumor range and size of the patient. 5. Nutritional and general physical condition must be able to tolerate the recommended radiotherapy and chemotherapy.

Exclusion criteria

1. Evidence of distant metastasis in stage IVc 2. Patients with isolated recurrence of cervical lymph nodes; 3. Patients have participated in other interventional trials for tumors 4. 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of severe late complicationsFrom enrollment to the three-year follow-up periodThe 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.

Secondary

MeasureTime frameDescription
Overall survival timeFrom enrollment to the three-year follow-up periodIt 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.
Local progression-free survival timeFrom enrollment to the three-year follow-up periodIt 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.
Short-term treatment responsesFrom enrollment to the three-month follow-up periodThe 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).

Countries

China

Contacts

CONTACTTaize Yuan, M.D., Ph.D.
taize.yuan@ccm.cn8620-32506195
STUDY_DIRECTORYuan Taize

private hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026