Nasopharyngeal Carcinoma
Conditions
Brief summary
This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.
Interventions
None listed
Sponsors
Fujian Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Age: 18 to 70 years old. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III). Initial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC/UICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0). Completion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.). Post-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx. ECOG Performance Status (PS): 0-1. Bone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced). Informed consent: Voluntary participation in the study and signing of written informed consent.
Exclusion criteria
History of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer). Partial response (PR) or complete response (CR) after induction chemotherapy. Severe uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus. Active infection or severe immunodeficiency diseases. Pregnant or breastfeeding women. Any mental or social disorders that may interfere with study evaluation or compliance. Other conditions deemed by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | Baseline, 1 year, 2 years, 3 years | The primary endpoint of this study is to compare the 3-year progression-free survival (PFS) rate between the two treatment groups. Disease progression will be assessed using RECIST 1.1 criteria, with imaging exams (such as MRI) used to monitor tumor size and progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Regional Recurrence-Free Survival | Baseline, 1 year, 2 years, 3 years | This secondary endpoint will evaluate the 3-year local regional recurrence-free survival (LRRFS) rate between the two treatment groups. |
| Overall Survival | Baseline, 1 year, 2 years, 3 years | This secondary endpoint will evaluate the 3-year overall survival (OS) rate. The OS rate will be compared between the re-induction chemotherapy followed by radiotherapy group and the direct radiotherapy group. |
| Distant Metastasis-Free Survival | Baseline, 1 year, 2 years, 3 years | This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate. |
| Complete Response Rate after Radiotherapy | 3 months post-treatment | This secondary endpoint will assess the rate of complete response (CR) after radiotherapy. |
| 3-4 Grade Acute Toxicity Incidence | through study completion, an average of 4-6 months | This secondary endpoint will assess the incidence of grade 3 or 4 acute toxicity, based on the Common Terminology Criteria for Adverse Events (CTCAE) scale. The toxicity will be assessed during the course of the treatment. |
Contacts
CONTACTYedong Huang, MD. PhD
Outcome results
None listed