Intensity-modulated proton therapy for recurrent nasopharyngeal cancer

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

This will try intensity-modulated proton radiotherapy to treat adults with unresectable recurrent nasopharyngeal cancer and may reduce severe side effects from repeat radiation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou Concord Cancer Center (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT07412314 on ClinicalTrials.gov

What this trial studies

This interventional study will deliver intensity-modulated proton radiotherapy to adults with biopsy-confirmed, non-metastatic recurrent nasopharyngeal carcinoma who are eligible for re-irradiation. Patients will be selected based on tumor stage (≥ T2b and/or positive nodes), ECOG performance status 0–1, and ability to tolerate treatment, and will be followed for tumor control and late radiation toxicities. The trial aims to generate higher-quality prospective evidence to compare safety, local control, and survival outcomes against historical IMRT results. Outcomes will include measures of acute and late toxicity, local progression-free survival, and overall survival.

Who should consider this trial

Good fit: Adults (≥18) with biopsy-confirmed, non-metastatic recurrent nasopharyngeal squamous cell carcinoma (WHO I–III) at stage ≥ T2b and/or with positive lymph nodes, ECOG 0–1, expected survival ≥6 months, and medically able to tolerate re-irradiation are ideal candidates.

Not a fit: Patients with distant metastasis (stage IVc), isolated recurrence limited to cervical lymph nodes, recent other malignancies within 5 years, active untreated infections, inability to tolerate re-irradiation, or who are enrolled in other interventional tumor trials are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could improve local tumor control and reduce severe late radiation toxicities, potentially prolonging survival and improving quality of life.

How similar studies have performed: Most prior evidence is from observational and retrospective series suggesting proton re-irradiation can reduce toxicity and may improve control compared with photon IMRT, but high-level randomized evidence is lacking.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Guangzhou Concord Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Guangzhou concord cancer center — Guanzhou, Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Taize Yuan, M.D., Ph.D.

Conditions Recurrent Nasopharyngeal Carcinoma; proton therapy; recurrent nasopharyngeal carcinoma