Nasopharyngeal Cancinoma (NPC)
Conditions
Keywords
radiotherapy, dose
Brief summary
This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.
Detailed description
All the patients receive intensity-modulated radiotherapy. If patients receive CR and EBV DNA undetectable when completing 50.88Gy radiation, they will continue to receive radiotherapy until 61.48Gy, then the patients would be randomised assigned ( 1:1 ) to reduced dose group (observation) or standard dose group (continue to receive radiotherapy until 69.96Gy). Patients with stage IA will receive radiotherapy alone, and patients with stage IB will receive concurrent chemoradiotherapy. For patients with stage IB, those assigned to reduced dose group will receive a total of 2 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle; those assigned to standard dose group will receive a total of 3 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle. This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy. The primary endpoint is 3-year locoregional relapse-free survival.
Interventions
RADIATIONReduced dose radiation
Reduced dose group would receive 61.48Gy radiation.
RADIATIONStandard dose radiation
Standard dose group would receive 69.96Gy radiation.
Sponsors
Hai-Qiang Mai,MD,PhD
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
1. Age 18-70, regardless of sex. 2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer\[AJCC\] edition). 3. Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation. 4. ECOG (Eastern Cooperative Oncology Group) score: 0-1. 5. Women in their reproductive years should ensure that they use contraception during the study period. 6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. 7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.5×ULN. 8. Renal function: serum creatinine \<1.5×ULN or creatinine clearance rate≥60mL/min. 9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
Exclusion criteria
1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I). 2. Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation. 3. Receiving radiotherapy or chemotherapy or targeted therapy previously. 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 6. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 7. Severe, uncontrolled medical conditions and infections. 8. At the same time using other test drugs or in other clinical trials. 9. Refusal or inability to sign informed consent to participate in the trial. 10. Other treatment contraindications. 11. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional relapse-free survival | 3 year | The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 year | Time from randomisation to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occurr first. |
| Overall survival | 3 year | Time from randomisation to death from any cause or censored at the date of the last follow-up. |
| Distant metastasis-free survival | 3 year | Time from randomistion to distant metastasis or death from any cause. |
| Incidence rate of adverse events (AEs) | 3 year | Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme. |
| Change of quality of life (QoL) score | 1 year | QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer (EORTC ) Quality of Life Questionnaire C30 (QLQ-C30) and EORTC QLQ-Head and Neck module (QLQ-H&N35) at 61.48Gy radiotherapy, at 1 month after radiotherapy, at 6 month after radiotherapy, and 12 month after radiotherapy.All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems. |
Countries
China
Contacts
Primary ContactHai-Qiang Mai, Dr.
Backup ContactQiu-Yan Chen, Dr.
Outcome results
None listed