Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma

Phase 3RecruitingNCT06912698

Hai-Qiang Mai,MD,PhD342 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

342

Conditions

Nasopharyngeal Cancinoma (NPC)

Interventions

Reduced dose radiationRADIATION

Reduced dose group would receive 61.48Gy radiation.

Standard dose radiationRADIATION

Standard dose group would receive 69.96Gy radiation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Locoregional relapse-free survival

The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first.

Time frame: 3 year

Secondary Outcomes

Progression-free survival

Time from randomisation to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occurr first.

Time frame: 3 year

Overall survival

Time from randomisation to death from any cause or censored at the date of the last follow-up.

Time frame: 3 year

Distant metastasis-free survival

Time from randomistion to distant metastasis or death from any cause.

Time frame: 3 year

Incidence rate of adverse events (AEs)

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.

Time frame: 3 year

Change of quality of life (QoL) score

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.

Central Contacts

Hai-Qiang Mai, Dr.

CONTACT

+8602087343380 maihq@sysucc.org.cn

Qiu-Yan Chen, Dr.

CONTACT

+8602087343380 chenqy@sysucc.org.cn

Data from ClinicalTrials.gov

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