A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA

• Status: Enrolling by invitation
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high incidence of lymphatic and hematological dissemination. Because of the inherent anatomic constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary treatment for NPC patients.

NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been used to treat NPC patients with advanced-stage diseases during recent 20 years. However, treatment outcome for locoregionally advanced NPC is still unsatisfactory.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: China Medical University Hospital; Kaohsiung Veterans General Hospital.; Mackay Memorial Hospital; National Cheng-Kung University Hospital; National Taiwan University Hospital; Taichung Veterans General Hospital
• Treatments: Cisplatin; Epirubicin; Mitomycin; Mitomycins; Tegafur

Criteria

Inclusion Criteria:

1.Histological proven NPC.

2.2010 AJCC stage II-IVB.

3.Age ≧ 20 years old.

4.Performance status of ECOG ≦ 2.

5.Finished RT ≧ 66 Gy (± induction and/or concurrent chemotherapy).

6.pEBV DNA > 0 copy/ml at 1±1 week post-RT.

7.Re-staging work-ups at 10±2 weeks post-RT showing no active lesions.

8.Adequate liver, renal, and bone marrow function 4 weeks before randomization.

9.Signed informed consent.

Exclusion Criteria:

1. Pathologically-proven the presence of locoregional disease and/or distant metastasis.

2. Unequivocally-shown active NPC (locoregional/distant) by imaging studies.

3. Inadequate RT.

4. Received any post-RT adjuvant chemotherapy.

5. pEBV DNA = 0 copy/ml at 1±1 week post-RT.

6. Previous delivery of cisplatin dose > 600 mg/m2.

7. Previous delivery of epirubicin > 360 mg/m2.

8. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of breast.

9. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.

10. Female patients who are pregnant or lactating.