Nasopharyngeal Cancinoma (NPC)
Conditions
Keywords
Nasopharyngeal Carcinoma, De-escalation, Radiotherapy
Brief summary
To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).
Detailed description
This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (NPC). The intervention involves comparing reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation for the low-risk clinical target volume (CTV). The objective is to compare the locoregional control, survival rate, toxicity, and quality of life between the two groups.
Interventions
RADIATIONRadiation Therapy
PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.
Sponsors
Sun Yat-sen University
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Affiliated Hospital of Guangdong Medical University
The University of Hong Kong-Shenzhen Hospital
Dongguan People's Hospital
Affiliated Cancer Hospital of Shantou University Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal \[ULN\]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).
Exclusion criteria
Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional relapse-free survival | 3 year | Defined as the time from randomization to either documented local and/or regional relapse or death from any cause (except for metastasis), whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 year | Defined as the time from randomization to death from any cause. |
| Failure-free survival | 3 year | Defined as the time from randomisation to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause, whichever occurred first. |
| Distant metastasis-free survival | 3 year | Defined as the time from randomization to documented distant metastasis or death from any cause (except for locoregional relapse). |
| Acute toxicities | 3 months | Occur within 3 months after RT. Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 5.0 scale. |
| Late toxicities | 3 year | Occur 3 months after RT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria |
| Patient's quality-of-life | 1 year | Quality-of-life (QoL) scores were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire Core 30 items (QLQ-C30) version 3.0 and the head and neck cancer module (QLQ-H and N35). |
Countries
China
Outcome results
None listed